MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM VIT E LINER +0MM; PROSTHESIS, EXTREMITIES

Catalog Number	00435003600
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device product code - phx.Concomitant medical products: item# 00434900813; lot# 62897960; item# 00435003600; lot# 64841052; item# 010000589; lot# 094720; item# 115310; lot# 929270; item# 115395; lot# 458290; item# 180552; lot# 263900; item# 180553; lot# 699760.Full establishment name - (b)(6).Report source: foreign - event occurred in (b)(6).Visual examination of the returned product identified heavy indentation around the anti-rotational slot on the device.No other damage was noted.Medical records were not provided.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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 an initial procedure was performed approximately two and a half (2.5) months ago when the poly liner was unable to be assembled to the stem due to cosmetic burrs interfering.A second poly liner was used to complete the surgery.Patient did not experience any harm as a result of the event.Attempts have been made and no further information has been provided.

• Brand Name: 36MM VIT E LINER +0MM
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12532756
• Report Number: 0001822565-2021-02759
• Device Sequence Number: 19182999
• Product Code: PHX
• UDI-Device Identifier: 00889024269392
• UDI-Public: (01)00889024269392(17)260208(10)64841052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2026
• Device Catalogue Number: 00435003600
• Device Lot Number: 64841052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/27/2021
• 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: NI
• Patient Sequence Number: 1