MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER¿¢ REVERSE, HUMERAL CUP, 0°, RETRO; SHOULDER PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent revision due to cup and inlay impingement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Mfr site- foreign: switzerland.Associated products: item number:01.04223.236, item name: anatomical shoulder¿ reverse, glenoid head, 36, lot number: 2336445.Item number: unknown, item name: unknown anatomical shoulder reverse humeral insert, lot number: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00492.As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The devices are used for treatment.Four intraoperative images were received.The first image shows the as reverse cup and liner in-vivo.The inferior portion/rim of the liner is notably worn and exposing the rim of the cup.The second picture received shows the recently explanted cup and liner in the surgical room.The exposed inferior rim of the cup is worn.The third image shows the exposed humeral stem interface, where the cup was inserted.Some sign of metallosis is evident.The glenosphere appears slightly in this image.The final image shows the exposed glenoid of the patient after all components were removed.No surgical reports or x-rays were received.The implant angle of the as reverse cup in relation to the glenosphere is unknown.Of note is the long implantation time of approximately 15 years.A definitive root cause cannot be determined.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.

• Brand Name: ANATOMICAL SHOULDER¿¢ REVERSE, HUMERAL CUP, 0°, RETRO
• Common Device Name: SHOULDER PROSTHESIS
• 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: 15474555
• Report Number: 0009613350-2022-00396
• Device Sequence Number: 20795471
• Product Code: PHX
• UDI-Device Identifier: 00889024479395
• UDI-Public: (01)00889024479395(17)120331(10)2375766
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K053274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.100
• Device Lot Number: 2375766
• 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: 05/31/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2007
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose