MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 9, 100 MM; ANATOMICAL SHOULDER SYSTEM

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Rupture (2208); Muscle/Tendon Damage (4532)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: md hybrid glenoid base 4mm d base 4mm; catalog#: 113954; lot#: 447550.Therapy date: unknown.The manufacturer received other source of documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient was implanted on the right side and suffered from a complete rupture of the subscapular tendon measuring more than 2 cm.No medical intervention.Revision surgery will be considered if necessary.

Event Description

Patient was implanted on the right side and underwent a revision surgery due to complete rupture of the subscapular tendon measuring more than 2 cm.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D10: medical products: anatomical shoulder domelock, humeral head, 50-18, r: 27.6mm; catalog#: 01.04212.505; lot#: 2828586.Anatomical shoulder domelock, dome, centric; catalog#: 01.04227.005; lot#: 2975075.Md hybrid glenoid base 4mm d base 4mm; catalog#: 113954; lot#: 447550.Therapy date: (b)(6) 2021.Additional information was received on (b)(6) 2021.Additionals: b2, b5, d6, d10.Corrections: b4, d8, g3, g6, h2, h5, h6, h10.The manufacturer received x-rays and other source documents (surgical reports) for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient was implanted an as shoulder system and suffered from a complete rupture of the subscapular tendon measuring more than 2 cm.The patient was initially handled conservatively and underwent a revision surgery on (b)(6) 2021.The event is indicated as an adverse event moderate in intensity, not related to the device or the instrumentation, but related to the surgical procedure.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: an x-ray review has been performed by a healthcare professional.Right shoulder arthroplasty with no obvious dislocation or fracture.Somewhat limited evaluation of the arthroplasty on the axillary view as the central glenoid screw is not well seen.Overall fit and alignment of the implants is appropriate.Osteopenia is present.No signs of loosening, radiolucency, osteolysis.No trauma is identified surgical report: the operative information form from the clinical study has been reviewed, and indicates that the anatomical shoulder system was combined with a biomet hybrid glenoid base.This is considered off-label use.No revision surgical report has been received for review.Patient data: year of birth: 1952; height: 180 cm; findings: general anesthesia/block.Deltopectoral approach.Subscapularis tendon release ¿ osteotomy.Anterior and inferior capsule release.Rotator cuff intact.Biceps pathologic.Normal bone quality.No intra-operative complications reported.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was not approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient was implanted an as shoulder system and suffered from a complete rupture of the subscapular tendon measuring more than 2 cm.The patient was initially handled conservatively and underwent a revision surgery on (b)(6) 2021.The event is indicated as an adverse event moderate in intensity, not related to the device or the instrumentation, but related to the surgical procedure.Medical records were received and reviewed, however no conspicuous findings relevant to the reported event have been identified.Further, no device was returned and a visual evaluation could not be performed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the investigation the reported event cannot be confirmed.The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of humerus firmly within the shallow socket of the shoulder.Rotator cuff injuries occur most often in people who repeatedly perform overhead motions in their jobs or sports.Degenerative tears can also occur as a result of a wearing down of the tendon that occurs over time.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.Common symptoms of a rotator cuff tear include pain at rest, pain when lifting, weakness, and crepitus.The surgeon states that there was no evidence that this was related to the device or the instrumentation, but related to the surgical procedure.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Event Description

See section h10.

Manufacturer Narrative

Event description: it was reported that the patient was implanted an as shoulder system and suffered from a complete rupture of the subscapular tendon measuring more than 2 cm.The patient was initially handled conservatively and underwent a revision surgery on (b)(6) 2021.The event is indicated as an adverse event moderate in intensity, not related to the device or the instrumentation, but related to the surgical procedure.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: an x-ray review has been performed by a healthcare professional.Right shoulder arthroplasty with no obvious dislocation or fracture.Somewhat limited evaluation of the arthroplasty on the axillary view as the central glenoid screw is not well seen.Overall fit and alignment of the implants is appropriate.Osteopenia is present.No signs of loosening, radiolucency, osteolysis.No trauma is identified - surgical report: the operative information form from the clinical study has been reviewed, and indicates that the anatomical shoulder system was combined with a biomet hybrid glenoid base.This is considered off-label use.No revision surgical report has been received for review.- patient data: year of birth: 1952; height: 180 cm; findings: general anesthesia/block.Deltopectoral approach.Subscapularis tendon release ¿ osteotomy.Anterior and inferior capsule release.Rotator cuff ¿ intact.Biceps ¿ pathologic.Normal bone quality.No intra-operative complications reported.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: certification issued by the notified body about the anatomical shoulder system indicates that since 2016 the anatomical shoulder heads ¿ also used for the domelock system ¿ are compatible and indicated for use in combination with the biomet comprehensive hybrid glenoid - modular hybrid glenoid base included.Therefore, this combination is approved.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient was implanted an as shoulder system and suffered from a complete rupture of the subscapular tendon measuring more than 2 cm.The patient was initially handled conservatively and underwent a revision surgery on 07 may2021.The event is indicated as an adverse event moderate in intensity, not related to the device or the instrumentation, but related to the surgical procedure.Medical records were received and reviewed, however no conspicuous findings relevant to the reported event have been identified.Further, no device was returned and a visual evaluation could not be performed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the investigation the reported event cannot be confirmed.The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of humerus firmly within the shallow socket of the shoulder.Rotator cuff injuries occur most often in people who repeatedly perform overhead motions in their jobs or sports.Degenerative tears can also occur as a result of a wearing down of the tendon that occurs over time.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.Common symptoms of a rotator cuff tear include pain at rest, pain when lifting, weakness, and crepitus.The surgeon states that there was no evidence that this was related to the device or the instrumentation, but related to the surgical procedure.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 9, 100 MM
• Type of Device: ANATOMICAL SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11271123
• MDR Text Key: 230014478
• Report Number: 0009613350-2021-00065
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024484894
• UDI-Public: 00889024484894
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K142403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.04211.093
• Device Lot Number: 2879170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 90 KG