MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM A GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	00-4349-036-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	03/29/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02636, 0001822565-2022-02637, 0001822565-2022-02676, 0001822565-2022-02677, 0001822565-2022-02678.Concomitant medical products: item#: 00434901213, 12mm a 130mm length humeral stem; lot#: 62248463.Item#: 00434903603, 36mm a +3mm offset poly liner; lot#: 62114032.Item#: 00834902502, tm rvs base plt 25mm post +2; lot#: 62274777.Item#: unknown, unknown screw length 36; lot#: unknown.Item#: unknown, unknown screw length 42; lot#: unknown.Item#: unknown, unknown glenoid bone void filler- autograft (glenoid); lot#: unknown.Item#: unknown, unknown simplex cement; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a right reverse shoulder arthroplasty.Subsequently, approximately a month and a half after the surgery the patient reported an increase of pain down their arm.The patient was diagnosed with nerve pain with numbness and prescribed a medication (lyrica 75mg).The patient is satisfied and all implant remain implanted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02636-1, 0001822565-2022-02637-1, 0001822565-2022-02676-1, 0001822565-2022-02677-1, 0001822565-2022-02678-1.Component codes: mechanical (g04) - head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: on (b)(6) 2013; visit.Improving; satisfied.Anteroposterior & axillary images taken: no significant findings.Ae increase in pain due to suspected nerve pain; prescribed lyrica 75 mg.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 36MM A GLENOSPHERE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15418841
• Report Number: 0001822565-2022-02638
• Device Sequence Number: 6554468
• Product Code: HSD
• UDI-Device Identifier: 00889024269088
• UDI-Public: (01)00889024269088(17)221231(10)62234748
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 00-4349-036-11
• Device Catalogue Number: 00434903611
• Device Lot Number: 62234748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White