MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 40-6; ANATOMICAL SHOULDER INVERSE/REVERSE

Model Number N/A

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: anatomical shoulder reverse, humeral cup, 0, retro, +6 mm medial offset; item# 0104223106; lot# 3007653; glenosphere, 40, 15; item# 0104441069; lot# 3003963; taper adaptor, l, 15; item# 0104440078; lot# 2996677.Therapy date: unknown.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on unknown side and underwent revision surgery due to disconnection.

Manufacturer Narrative

Additional information which was received on feb 24, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer did not receive any documents 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).

Event Description

Patient was implanted on unknown side and underwent revision surgery due to disconnection.

Event Description

Patient was implanted on an unknown side and underwent revision surgery due to disconnection.According to the surgical report, there was found that throughout the joint there was pronounced metallosis.The humeral shell had also been rubbed off the glenosphere.Therefore the surgeon changed all mobile parts.

Manufacturer Narrative

D10: medical products: anatomical shoulder, reverse, humeral cup, 0, retro, +6 mm medial offset.Catalog#: 01.04223.106; lot#: 3007653.Glenosphere, 40 15; catalog#: 01.04441.069; lot#: 3003963.Taper adaptor, l, 15; catalog#: 01.04440.078; lot#: 2996677.Therapy date: (b)(6) 2021.Additional information was received on mar 03, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received x-rays and other source documents(revision report) 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

Investigation results were made available.Event description: it was reported that the patient received a right reverse shoulder replacement on (b)(6) 2020 and was revised on (b)(6) 2021 due to disconnection.When the humeral insert was revised, the surgeon also replaced the humeral cup, the glenosphere and the taper.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: a reverse-type right shoulder arthroplasty is present.There is no evidence of fracture or implant loosening.Chronic ossification is noted along the proximal humeral diaphysis.Overall fit and alignment appear maintained.Bone quality is within the normal range.On the images from (b)(6) 2021 a gap between humeral cup and glenosphere is clearly visible.This gap is gone on the corresponding images taken on (b)(6) 2021.- images: a total of 4 images of the removed components on a surgical drape were submitted.Two images show the removed inlay, which is still bloody, with adherent reddish and blackish tissue remnants covering almost the entire anchorage surface, except for the bottom surface, which appears clean.The articulating surface appears inconspicuous.The reference and lot numbers are not legible.Two other images show a clean humeral cup and glenosphere with a mounted taper adapter with some blood and tissue residue.Based on the available images, the parts cannot be assessed in more detail.Please note that the pictures are not shown in this report.- surgical report: surgical report, dated (b)(6) 2021: diagnosis: inlay dislocation following basic movement on (b)(6) 2021.Condition after latissimus dorsi transfer right via deltopectoral approach on (b)(6) 2020.Indication: the patient has had an inlay dislocation temporally correlated to chiropractic manipulation, but actually of unclear genesis since (b)(6) 2021.For this reason, the indication for surgical revision is given.Treatment: replacement of mobile parts shoulder right inverse/reverse (stem remained implanted).Description of procedure: opening of the joint.Display of the dislocated polyethylene, which is located anteriorly of the glensophere.Removal after photographical documentation.There is extensive metallosis in the whole joint.The humeral cup as well as the glenosphere are also worn.Therefore, all mobile parts are revised.Extraction of the humeral cup, which does not show any defects.The stem is stable and remains implanted.Easy removal of the glenosphere, which has multiple scratches but is not damaged.Also underneath metallotic tissue.Trial reposition with the previously used humeral cup and polyethlyene, which results in lack of tension.Implantation of new components.Product evaluation: - no product was returned; therefore, product evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.- dhr review: review of the device history records identified no relevant deviations or anomalies during manufacturing.Conclusion: it was reported that the patient received a right reverse shoulder replacement on (b)(6) 2020 and was revised on (b)(6) 2021 due to disconnection.When the humeral insert was revised, the surgeon also replaced the humeral cup, the glenosphere and the taper.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).The missing gap between the humeral cup and the glenosphere visible on the radiographs from (b)(6) 2021 indicates dislocation of the inlay.This is supported by the image of the removed inlay with tissue remnants covering almost the entire anchorage surface, which indicates that the inlay was dislocated in vivo for some time.In addition, the revision report states that the inlay was found dislocated anterior to the glenosphere.From the medical records provided, it appears that possible contributing factors that may have caused or contributed to the reported dislocation of the inlay include inappropriate motion during chiropractic mobilization and joint laxity.However, due to the unavailability of the components, no device investigation could be performed.Therefore, the cause of the dislocation could not be determined.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

Investigation has been completed.

• Brand Name: ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 40-6
• Type of Device: ANATOMICAL SHOULDER INVERSE/REVERSE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11364022
• MDR Text Key: 233028349
• Report Number: 0009613350-2021-00102
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00889024481428
• UDI-Public: 00889024481428
• Combination Product (y/n): N
• PMA/PMN Number: K053274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.406
• Device Lot Number: 2994600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 83