MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 CD TOP; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that, during insertion of the provisional articular surface, a little piece of plastic on the back side posterior fractured.All the pieces have been retrieved.No harm to the patient and no delay in surgery.There is no additional information available at this time.
Additional Manufacturer Narrative
Reported event was unable to be confirmed.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) and receiving inspection reports were reviewed for deviations and/ or anomalies with the following anomalies/ deviations identified: scrap one-piece part has hole undersize condition.The supplier history records were reviewed and researched for deviations and/ or anomalies with no deviations/ anomalies identified.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual evaluation of the returned product exhibits signs of repeated use and small chips have fractured off the medial and lateral side all pieces were not returned reference attached photographs.Medical records were not provided.Root cause remains the same.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: PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 CD TOP
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10613436
• Report Number: 0001822565-2020-03409
• Device Sequence Number: 2719877
• Product Code: JWH
• UDI-Device Identifier: 00889024245310
• UDI-Public: (01)00889024245310
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113369
• 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,Followup
• Report Date (Section B): 02/24/2021

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: 42527400510
• Device Lot Number: 64159171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 12/28/2020; 02/23/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/29/2020; 02/24/2021
• 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