MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER, REVERSE, HUMERAL CUP, 0, RETRO; ANATOMICAL SHOULDER SYSTEM

Model Number	N/A
Medical Device Problem Codes	Material Disintegration (1177); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: anatomical shoulder, humeral stem, cemented, 14; catalog#: 01.04211.142; lot#: 2322858; unknown (humeral bearing); catalog#: unknown ; lot#: unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.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: 0009613350-2021-00629.Product not available.
Event or Problem Description
It was reported that the revision of old anatomic reverse shoulder due to notching causing the bearing to wear out.Patient outcome - revision.
Additional Manufacturer Narrative
Event description: it was reported that an anatomical reverse shoulder replacement had to be revised due to notching and wear of the bearing.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.- three photographs were received.Image 1: humeral cup and humeral inlay attached to each other with blood on the visible surfaces and positioned in a tray.Image 2: humeral stem on a blue surgical drape with visible labeling and some blood on the visible surfaces.Image 3: undated radiograph which cannot be evaluated in more detail due to poor image quality.- otherwise, no medical data relevant to the case has been received.Product evaluation: - the products were discarded; 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 could not be performed due to missing product identification.- dhr review: review of the device history records could not be performed due to missing product identification.Conclusion: it was reported that an anatomical reverse shoulder replacement had to be revised due to notching and wear of the bearing.The devices were discarded, and no medical records such as surgical reports and labeled radiographs (dated, view) were provided.Based on the images provided, a detailed assessment could not be performed.Therefore, the reported event cannot be confirmed and a root cause analysis could not be performed.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).
Event or Problem Description
No change to previously reported event.

• Brand Name: ANATOMICAL SHOULDER, REVERSE, HUMERAL CUP, 0, RETRO
• Common Device Name: ANATOMICAL SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 12909076
• Report Number: 0009613350-2021-00628
• Device Sequence Number: 17384116
• Product Code: KWS
• UDI-Device Identifier: 00889024285729
• UDI-Public: 00889024285729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 02/08/2022

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: 01.04223.100
• Device Lot Number: 2317765
• 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: 11/02/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown