MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: catalog#: 0104201072; lot#: unknown anatomical shoulder, humeral stem, uncemented, 7.Catalog#: 0104223106; lot#: unknown anatomical shoulder reverse, humeral cup.Catalog#: 0104223236; lot#: unknown anatomical shoulder reverse, glenoid head, 36.Catalog#: unknown; lot#: unknown inverse/reverse humeral pe-inlay generic.The manufacturer did not receive x-rays, or other source documents for review.As no lot number was provided, the device history records could not be reviewed.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).The following reports are associated with this event: 0009613350-2021-00571, 0009613350-2021-00573.Explantation unknown.
Event or Problem Description
Patient was implanted on an unknown side and post-implantation experienced loosening of the glenoid, left shoulder, general failure of the material and recurrent pain on the left side along with acute subacromial bursitis and right rib fracture, vd.For screw breakage and loosening of the glenoid component.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: h2, h6, h10.Event description: it was reported that there was recurrent left should pain, loosening of the glenoid and screw breakage.Review of received data: - no medical data has been received.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: - no product was returned; therefore, product evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the compatibility check could not be performed because the product identification is not available for all components.- dhr review: review of manufacturing records could not be performed due to missing lot numbers.Conclusion: it was reported that there was recurrent left shoulder pain, loosening of the glenoid and screw breakage.Neither medical records nor the devices or pictures thereof have been made available.Therefore, the course of events and the condition of the involved components remain unknown.Consequently, the reported event cannot be confirmed and possible causes could not be investigated due to the significant lack of information.The investigation did not identify a nonconformance or a complaint out of box (coob).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 REVERSE, SCREW SYSTEM, 4.5-30
• Common Device Name: ZIMMER TRABECULAR METAL REVERSE 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: 12793531
• Report Number: 0009613350-2021-00572
• Device Sequence Number: 14609881
• Product Code: KWS
• UDI-Device Identifier: 00889024483026
• UDI-Public: 00889024483026
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female