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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscular Rigidity (1968)
Date of Event	07/24/2019
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.Additional associated products and mdrs: 00596404010 articular surface size ef 10 mm height, lot# 64182222, mdr: 0001822565-2022-00076; 00597206535 all poly patella standard cemented 35mm 9.0mm, lot# 64129887, mdr: 0002648920-2022-00009.
Event or Problem Description
It was reported the patient underwent a left knee procedure.The patient suffered from a tendon rupture approximately 2 months post procedure.Subsequently, the patient underwent a manipulation under anesthesia 3 months post tendon rupture due to stiffness.Attempts to gather more information are underway, however, no additional information is available at this time.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
Event or Problem Description
It was reported initial left total knee arthroplasty.Approximately 2 months post procedure the patient had quadriceps tendon rupture with repair.The patient was in an immobilized splint with no rom for three months.Three months after the tendon repair the patient had manipulation under anesthesia do to stiffness related to being in splint and not able to perform rom.Components remain intact.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: FEMORAL COMPONENT OPTION SIZE F LEFT COMPATIBLE W/ LPS-FLEX PROLONG
• Common Device Name: PROSTHESIS, KNEE
• 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: 13252640
• Report Number: 3007963827-2022-00017
• Device Sequence Number: 14640881
• Product Code: JWH
• UDI-Device Identifier: 00889024001138
• UDI-Public: (01)00889024001138(17)291031(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
• Report Date (Section B): 02/01/2022

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 Device Available for Evaluation?: No
• 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
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG