MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 46-16, R=26.1MM; ANATOMICAL SHOULDER DOMELOCK SYSTEM

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received 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.(b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to pain.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Investigation results were made available.Event description: the patient was implanted on (b)(6) 2018 and underwent revision surgery on (b)(6) 2020 due to pain.The radiographs showed radiolucency at the humeral component, cortical ballooning and varus remodelling.During revision surgery the humeral component could be removed easily.Review of received data: medical data is not available due to patient privacy policy.In addition, only the reference number of the humeral head was reported, although the humeral head is not directly anchored in the bone.Therefore, it can be assumed that the reported radiolucency refers to either the glenoid component and/or the humeral stem.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only one product is known.Dhr review: review of the device history records could not be performed due to insufficient device identification.Conclusion: the patient was implanted on (b)(6) 2018 and underwent revision surgery on (b)(6) 2020 due to pain.The radiographs showed radiolucency at the humeral component, cortical ballooning and varus remodelling.During revision surgery the humeral component could be removed easily.It can be assumed that the reported radiolucency relates to either the glenoid component and/or the humeral stem, but product information is not known for either component.Due to significant lack of information an investigation could not be performed, nevertheless based on the given information there is no indication of a non-conformance or 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 DOMELOCK, HUMERAL HEAD, 46-16, R=26.1MM
• Common Device Name: ANATOMICAL SHOULDER DOMELOCK SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10552428
• Report Number: 0009613350-2020-00411
• Device Sequence Number: 19619384
• Product Code: HSD
• UDI-Device Identifier: 00889024480377
• UDI-Public: 00889024480377
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 01.04212.465
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Age: 63 YR
• Patient Weight: 67