MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; PROSTHESIS, EXTREMITIES

Catalog Number	115395
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01164.Device product code: phx.Concomitant medical devices: part# 010000589; lot# 664310; part# 115395; lot# 466350; part# 113652; lot# 565440; part# xl-115363; lot# 596940; part# 115370; lot# 632780; part# 180552; lot# 339050; part# 180552; lot# 819320; part# 180550; lot# 961080; part# 180552; lot# 035420; part# 115310; lot# 669910.Visual examination of the returned product identified no damage on the taper adapter.The baseplate was not returned for evaluation.Dimensional analysis was not performed as the taper adapter was impacted into the baseplate.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: found glenosphere sitting in base plate disassociated, plate and stem intact dhr was reviewed and no discrepancies relevant to the reported event were found.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
It was reported that a patient underwent a right shoulder arthroplasty approximately nine (9) months ago.Subsequently the patient disassociated during pt, and was revised approximately three (3) months post primary implantation.Attempts have been made and no further information has been provided.

• Brand Name: COMP RVS CNTRL 6.5X25MM ST/RST
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10385276
• Report Number: 0001825034-2020-03098
• Device Sequence Number: 19694601
• Product Code: PHX
• UDI-Device Identifier: 00880304677074
• UDI-Public: (01)00880304677074
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 115395
• Device Lot Number: 466350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/10/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80