MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA STANDARD SIZE 32 MM DIAMETER 8.5 MM THICKNESS CEMENTED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Age or date of birth- dob (b)(6).Concomitant medical products- femoral component option size f left, item# 00595601601.Lot# 63525610.Stemmed tibial component precoat size: 5, item# 00598004701, lot# 63503873.Articular surface regular constraint, item# 90597004010.Lot# 63129290.Report source: (b)(6).Customer has not indicated whether or not 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 a patient was revised approximately one year and nine months¿ post implantation due to a fractured patella.There is no additional information available at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device was reported in error.The initial report was submitted in error and should be voided.Additional information was received indicating that the cause of the fall was due to a slip of the contralateral lower extremity going down stairs and no components were removed therefore; the event is not device related.
Event or Problem Description
Upon reassessment of the reported event, it was determined that this device was reported in error.The initial report was submitted in error and should be voided.Additional information was received indicating that the cause of the fall was due to a slip of the contralateral lower extremity going down stairs and no components were removed therefore; the event is not device related.

• Brand Name: ALL POLY PATELLA STANDARD SIZE 32 MM DIAMETER 8.5 MM THICKNESS CEMENTED
• 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: 10489028
• Report Number: 0002648920-2020-00395
• Device Sequence Number: 2925578
• Product Code: JWH
• UDI-Device Identifier: 00889024215146
• UDI-Public: (01)00889024215146
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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 Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00597206532
• Device Lot Number: 63689667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 90