MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a left knee revision approximately three-and-a-half years post-implantation due to instability.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00065.Medical products: articular surface medial congruent (mc) left 11 mm height catalog#: 42512100511 lot#: 63667962.Tibia cemented 5 degree stemmed left size d catalog#: 42532006701 lot#: 63682977.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately three-and-a-half years post-implantation due to instability.Operative report states there was poly failure and subsequent metallosis from the femur wearing through the poly in the medial aspect of the tibia with fragmented poly and erosive wear in the tibial component.There was significant black metallosis noted throughout the soft tissue.Significant wear noted on the medial aspect of the patella.No full defects and stably cemented, therefor left in place.Burnishing on the femoral condyle of the implant but otherwise intact.Fragmented poly, 10 major and other minor fragments which appeared to have developed a defect in the posteromedial portion.Stability restored despite previous posteromedial laxity.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Suggested component code: mechanical g4-femur.Complaint sample was evaluated and the reported event was confirmed, as well as through medical records.Visual examination of the returned product identified sign of use.The femur has excessive wear on the medial side.Medical records were provided and reviewed by a health care professional.Review of the available records identified patient suffered from pain, instability and metallosis due to excessive wear on the poly; which lead to interaction between tibial and femur.However, the femur was found to be intact apart from burnishing on the condyle.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause was unable to be determined.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: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 8
• 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: 13712824
• Report Number: 3007963827-2022-00064
• Device Sequence Number: 14811013
• Product Code: JWH
• UDI-Device Identifier: 00889024230378
• UDI-Public: (01)00889024230378(17)260531(10)63355103
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42502606401
• Device Lot Number: 63355103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 06/30/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/12/2022; 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2016
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 54 KG