MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign : (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device identified that the dovetail feature was flared out and compressed.The device also exhibits signs of use(gouges).Device history record (dhr) reviewed and no discrepancies were found.Damage to the dovetail feature can occur if the articular surface is not correctly placed and oriented before pushing it into the tibial plate using the inserter instrument.Detailed instructions for inserting the articular surface are provided in the zimmer® mis multiple-reference 4 in 1 femoral instrumentation surgical technique and the surgical tip: articular surface inserter proper technique & use guidance document.The dovetail compression identified during the evaluation of the returned product indicates that the articular surface was not properly aligned being pushed in with the inserter.Therefore, the root cause of the reported issue can be attributed to user error.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the device insert had a manufacturing defect.This occurred during a case, but there were no complications during the procedure.No additional information available.

• Brand Name: ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9987977
• Report Number: 0001822565-2020-01426
• Device Sequence Number: 16667253
• Product Code: JWH
• UDI-Device Identifier: 00889024210905
• UDI-Public: (01)00889024210905
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00596202210
• Device Lot Number: 64413691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/22/2020
• 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: N/A
• Patient Sequence Number: 1