MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PETELLA STANDARD CEMENTED SIZE 35 MM DIAMETER 9.0 MM; PROSTHESIS, KNEE

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
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.
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: quadricep tendon rupture from several falls.The standard approach to total knee replacement involves cutting the quadriceps tendon.The tendon can take up to 6 weeks or longer to heal, requiring ambulatory aids until restoration of the joint and strengthening of the supporting structures is achieved.During recovery, home exercises and physical therapy are prescribed to prevent atrophy, weakness, or laxity of the attached quadriceps muscles to prevent falls or trauma.Any falls due to this weakness places the patient at increased risk for rupture or dehiscence of the tendon during the healing process.A repair of the quadriceps tendon was required, and the patient was placed in an immobilizer to prevent further damage and allow proper healing.When cleared for exercises by the surgeon, the supporting muscles require additional strengthening to prevent further complications.This complaint was confirmed.The root cause of the reported issue is attributed to the patient falling, however a definitive root cause of the patient fall cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products: 00598004701, stemmed tibial component precoat size 5, lot#: 63918953.00596404010, articular surface size ef 10 mm height, lot#: 64182222.00596401651, femoral component option size f left, lot#: 64112563.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.

• Brand Name: ALL POLY PETELLA STANDARD CEMENTED SIZE 35 MM DIAMETER 9.0 MM
• 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14270359
• Report Number: 0002648920-2022-00112
• Device Sequence Number: 5842864
• Product Code: JWH
• UDI-Device Identifier: 00889024215153
• UDI-Public: (01)00889024215153(17)260831(10)64129887
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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 Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00597206535
• Device Lot Number: 64129887
• 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
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG