MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-3; ANATOMICAL SHOULDER SYSTEM

Model Number N/A

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Date 10/13/2021

Event Type  Injury  

Event Description

It was reported that there was a revision due to dislocation and metallosis.

Manufacturer Narrative

Medical product: glenosphere 36 mm diameter; catalog#: 00-4349-036-11; lot#: 64973219.Base plate 15 mm post length uncemented; catalog#: 00-4349-015-00; lot#: 64889023.Anatomical shoulder, reverse, screw system, 4.5-36; catalog#: 01.04223.036; lot#: 3043246.Anatomical shoulder, reverse, screw system, 4.5-27; catalog#: 01.04223.027; lot#: 3021276.Anatomical shoulder, humeral stem, cemented, 7, 90 mm; catalog#: 01.04211.073; lot#: 2994864.Anatomical shoulder, reverse, humeral cup, retro; catalog#: 01.04223.100; lot#: 3060197.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6 correction: a2,b4, b5, g3, g6, h3, h10.Investigation and conclusion 1.Event description: it was reported that an initial reverse total shoulder arthroplasty was performed on (b)(6) 2021.Subsequently, the patient underwent revision of the glenosphere and poly insert on (b)(6) 2021 due to pain, limited mobility, and metallosis secondary to disassociation of the glenosphere from the baseplate.Harm: s3 - exposure to anesthesia, moderate hazardous situation: reported issue is not device related.2.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.- surgical report: the implantation report dated (b)(6) 2021 has been received.Indication: humeral head necrosis following subcapital humeral fracture and secondary dislocation procedure: removal of metal place and implantation of inverse shoulder tep cemented - patient data received - implant labels for the implantation dated (b)(6) 2021 received.- signed patient consent form received - timeline report by the nurse review group (nrg) documented in linked warsaw (zimmer inc) complaint with the following findings related to review of the received implantation report: - unknown plate and screws removed, 1 screw had migrated and was removed - reverse tsa cemented into place without complications 3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.4.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: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that an initial reverse total shoulder arthroplasty was performed on (b)(6) 2021.Subsequently, the patient underwent revision of the glenosphere and poly insert on (b)(6) 2021 due to pain, limited mobility, and metallosis secondary to disassociation of the glenosphere from the baseplate.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).Neither x-rays, the surgical report for revision, nor devices or photos of the devices were received; therefore the condition of the components is unknown.Patient factors that may have affected the performance of the components are unknown.Adherence to rehabilitation protocol is unknown.Based on the received product experience report (per) and the e-mail correspondence as well as the received patient consent form the reported event can be confirmed.The revision of the poly insert is likely concomitant to the event of glenosphere disassociation from the baseplate.However, 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

Investigation results are now available.

Manufacturer Narrative

This report is being filed to relay additional information, which was unknown at the time of the previously submitted report.The device was returned for analysis.Investigation of the reported event has been updated.Investigation and conclusion: 1.Event description: it was reported that an initial reverse total shoulder arthroplasty was performed on (b)(6), 2021.Subsequently, the patient underwent revision of the glenosphere and poly insert on (b)(6), 2021 due to pain, limited mobility, and metallosis secondary to disassociation of the glenosphere from the baseplate.Harm: s3 - exposure to anesthesia, moderate.Hazardous situation: reported issue is not device related.2.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.- surgical report: the implantation report dated (b)(6), 2021 has been received.Indication: humeral head necrosis following subcapital humeral fracture and secondary dislocation.Procedure: removal of metal place and implantation of inverse shoulder tep cemented.- patient year of birth 1939, female, 74kg, 168cm - implant labels for the implantation dated (b)(6), 2021 received.- signed patient consent form received.- timeline report by the nurse review group (nrg) documented in linked zimmer inc.(warsaw, usa) complaint with the following findings related to review of the received implantation report: - unknown plate and screws removed, 1 screw had migrated and was removed.- reverse tsa cemented into place without complications.3.Product evaluation: - visual examination: the complained product was returned to the warsaw, usa site and pictures were provided to zimmer switzerland manufacturing gmbh.A visual examination of these provided pictures was performed.A large portion of the outer rim of the liner, about 1/4 of the circumference, is deformed, likely resulting after the reported event of glenosphere disassociation from the baseplate.There are several metallic particles embedded in the articulating surface of the liner, possibly deriving from the disassociated glenosphere.Apart from these two mentioned phenomena, the liner shows normal signs of wear.4.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: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that an initial reverse total shoulder arthroplasty was performed on (b)(6), 2021.Subsequently, the patient underwent revision of the glenosphere and poly insert on (b)(6), 2021 due to pain, limited mobility, and metallosis secondary to disassociation of the glenosphere from the baseplate.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).Neither x-rays nor the surgical report for revision were received.Patient factors that may have affected the performance of the components are unknown.Adherence to rehabilitation protocol is unknown.The explanted liner was returned and a visual examination was performed.A large portion of the outer rim of the liner, about 1/4 of the circumference, is deformed, likely resulting after the reported event of glenosphere disassociation from the baseplate.There are several metallic particles embedded in the articulating surface of the liner, possibly deriving from the disassociated glenosphere.Apart from these two mentioned phenomena, the liner shows normal signs of wear.Based on the received product experience report (per) and the e-mail correspondence as well as the received patient consent form the reported event can be confirmed.The revision of the poly insert is likely concomitant to the event of glenosphere disassociation from the baseplate.However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer's reference: (b)(4).

Event Description

This report is being filed to relay additional information, which was unknown at the time of the previous submitted report.Device was received by manufacturer for visual examination.Investigation results have been updated.

• Brand Name: ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-3
• 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: 12786074
• MDR Text Key: 280571936
• Report Number: 0009613350-2021-00563
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024481381
• UDI-Public: 00889024481381
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193099
• 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
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.363
• Device Lot Number: 2944588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 74 KG