MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM NON-POROUS 13 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, EXTREMITIES

Catalog Number	00435001313
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02236, 0001822565-2020-02245.Concomitant medical products: poly liner - part# 00434906506, lot# 64163174.Unk glenoid head.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.
Event or Problem Description
It was reported patient underwent a reverse shoulder arthroplasty approximately five (5) months ago.Approximately one (1) month post implantation, patient underwent a revision due to pain, dislocation, and the poly liner disengaging from the stem.Surgeon only removed and replaced a new poly liner.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed were reviewed and identified open reduction and revision of right rtsa humeral component, poly spacer.Presented with increased pain, x-ray showed a dislocated shoulder.Closed reduction attempted but unsuccessful.Upon opening, the humeral poly component was noted to be displaced anterior and off the humeral stem.X-rays were not sent for mmi review as they do not enhance the investigation.Device history record 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HUMERAL STEM NON-POROUS 13 MM STEM DIAMETER 130 MM STEM LENGTH
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10186918
• Report Number: 0001822565-2020-02237
• Device Sequence Number: 908151
• Product Code: HSD
• UDI-Device Identifier: 00889024269323
• UDI-Public: (01)00889024269323
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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 Catalogue Number: 00435001313
• Device Lot Number: 63754535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention