MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices - tibia cemented 5 degree.Stemmed right size f: 42532007502: 77005090; articular surface fixed.Bearing ultracongruent.(uc) right 11 mm height: 42522200511: 62815750.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
Event or Problem Description
It was reported that patient underwent right total knee arthroplasty approximately three years ago.Subsequently, the patient had a painful and unstable knee.There was a planned surgery for a change of the articular surface, however the femoral component was loose and required revision.Revision completed using non zimmer biomet system.The surgeon stated the cement/bone interface on the medial femoral condyle had failed - no cancellous interdigitalization, due to cement technique error.Attempts have been made and no further information has been provided.".
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.The results of the investigation are as follows: no product was returned; visual and dimensional evaluations could not be performed.A photograph of explanted femoral component shows some material that is probably a mixture of bone and bone cement.Review of the device history records identified no related deviations or anomalies during manufacturing.The surgeon stated that the cement was not adequately applied and hence the root cause can be attributed to user error.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: PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 9
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11527198
• Report Number: 3007963827-2021-00065
• Device Sequence Number: 4537396
• Product Code: JWH
• UDI-Device Identifier: 00889024230408
• UDI-Public: (01)00889024230408(17)270331(10)63618637
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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 Model Number: N/A
• Device Catalogue Number: 42502606602
• Device Lot Number: 63618637
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 95