MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX ARTICULAR SURFACE SIZE CD 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a bilateral knee arthroplasty when the surgeon attempted to insert the articular surface, the device could not be implanted after several attempts.The surgeon utilized the articular surface intended for the patient's other knee to complete the operative side and the contralateral replacement could not be completed.The surgery was delayed an hour, however, no patient complications were reported.Attempts have been made to obtain additional information, however, no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified damage to the distal surface (nicked/gouged) and the dovetail feature was compressed and flared out.The device history records were reviewed and no discrepancies were identified.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before utilizing the inserter instrument.Detailed instructions for inserting the articular surface are provided in the surgical technique.The root cause is attributed to use error.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: NEXGEN LPS-FLEX ARTICULAR SURFACE SIZE CD 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11333913
• Report Number: 0001822565-2021-00417
• Device Sequence Number: 1034779
• Product Code: JWH
• UDI-Device Identifier: 00889024211766
• UDI-Public: (01)00889024211766(17)270430(10)64377322
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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 Model Number: N/A
• Device Catalogue Number: 00596403010
• Device Lot Number: 64377322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: N/A
• Patient Sequence Number: 1