MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE STEM; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00414.
Event or Problem Description
It was reported the patient was implanted with a reverse shoulder over a year ago.Subsequently, the patient was revised a couple of months ago due to the poly disengaging from the stem.A second revision was recently performed due to another disengaged poly and possible infection.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g4; g7; h1; h2; h3; h6 corrected: e2; e3 d11: unk glenoid head, unk baseplate, unk screw, unk screw.A tm reverse stem was returned for evaluation.Visual examination of the returned product identified bone debris embedded on the surface.Surface scratches were also identified on the stem.Dimensional analysis was performed during manufacturing and were conforming to print specifications.Insufficient information provided.Unable to perform a compatibility check.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02059, 0001822565-2020-02060, 0001822565-2020-02061, 0001822565-2020-02062.

• Brand Name: TM REVERSE STEM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9649130
• Report Number: 0001822565-2020-00415
• Device Sequence Number: 10888058
• Product Code: HSD
• UDI-Device Identifier: 00889024268975
• UDI-Public: (01)00889024268975
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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 Model Number: N/A
• Device Catalogue Number: 00434901413
• Device Lot Number: 64141262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.; UNKNOWN BASEPLATE PN: UNKNOWN LN: UNKNOWN.; UNKNOWN GLENOSPHERE PN: UNKNOWN LN: UNKNOWN.; UNKNOWN HUMERAL BEARING PN: UNKNOWN LN: UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention