MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE CD 10 MM HEIGHT; 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	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00598003701 - stemmed tibial component precoat size 3 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 64777668 report source: foreign country: (b)(6).Customer 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 the articular surface could not assemble with the tibial plateau during surgery.Multiple attempts were made, however, it still failed to match.There was a 20 minute delay in surgery.The surgeon used a different articular surface to complete the operation.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; d9; g3; g6; h1; h2; h3; h6.Visual evaluation of the returned implant shows signs of use.The dovetail feature was compressed and flared out.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in lps-flex fixed bearing knee surgical technique.The root cause is 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
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE SIZE CD 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12364432
• Report Number: 0001822565-2021-02377
• Device Sequence Number: 11747005
• Product Code: JWH
• UDI-Device Identifier: 00889024211766
• UDI-Public: (01)00889024211766(17)281109(10)64935669
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 64935669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Weight: 50