MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT OPTION SIZE F LEFT COMPATIBLE W/ LPS-FLEX PROLONG; UNCOATED KNEE FEMUR PROSTHESIS, METALLIC

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 the patient underwent a left knee procedure.Subsequently, the patient suffered from a tendon rupture approximately 2 months post procedure.Attempts to gather more information are underway, however, no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the patient underwent a left knee procedure.Subsequently, the patient had several falls with quadriceps tendon rupture.Approximately 2 months post procedure the tendon was repaired without complications.No additional information is available.
Event or Problem Description
Void - upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The initial report should be voided.
Additional Manufacturer Narrative
Void - upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The initial report should be voided.A new mdr was created under the associated product: 00597206535, all poly patella standard cemented size 35 mm diameter 9.0 mm lot# 64129887 mdr: 0002648920-2022-00112.

• Brand Name: FEMORAL COMPONENT OPTION SIZE F LEFT COMPATIBLE W/ LPS-FLEX PROLONG
• Common Device Name: UNCOATED KNEE FEMUR PROSTHESIS, METALLIC
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13252252
• Report Number: 3007963827-2022-00016
• Device Sequence Number: 19963413
• Product Code: JWH
• UDI-Device Identifier: 00889024001138
• UDI-Public: (01)00889024001138(17)281031(10)64112563
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P060037
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596401651
• Device Lot Number: 64112563
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/11/2022; 04/29/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/04/2022; 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG