MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femur cemented cruciate retaining (cr) catalog # 42502006002 lot # 64276519.Tibia cemented 5 degree stemmed catalog # 42532006402 lot # 64075020.Articular surface fixed bearing ultracongruent (uc) catalog # 42521200410 lot # 64090936.Persona cem fem/cem tib/s catalog # 98-0002-400-00 lot # unknown customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Multiple mdr reports were filled for this event: 3007963827-2020-00329, 3007963827-2020-00330, 3007963827-2020-00331.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient experienced pain, alignment issues and broken bone in her foot.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: ALL POLY PATELLA
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11055416
• Report Number: 0002648920-2020-00538
• Device Sequence Number: 2651639
• Product Code: JWH
• UDI-Device Identifier: 00889024247635
• UDI-Public: (01)00889024247635
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000032
• Device Lot Number: 64441505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/25/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 91