MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CRUCIATE RETAINING CEMENTED FEMORAL COMPONENT RIGHT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products- persona ultracongruent fixed bearing articular surface right 12mm catalog #: 42522200412 lot #: 62988948, persona stemmed cemented tibial component right size d catalog #: 42532006702 lot #: 63390847.Report source: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the explanted device could not be found.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 the patient underwent a right knee arthroplasty revision to address femoral component loosening approximately two (2) years post-operatively.Initial operative notes identified that the surgeon elected intraoperatively to perform total knee arthroplasty versus partial knee arthroplasty due to patient condition, however, no intraoperative complications were identified.Revision operative notes identified clear loosening in the cement bone interface of the femoral component.There was minimal bone loss with removal of the implant and the bone was identified to be sclerotic without lytic parts.There was no indication of infection and no evidence of tibial component loosening.The femoral and polyethylene articular surface were removed, however, the polyethylene showed no abnormalities.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event confirmed via medical records and x-ray review.Revision operative notes identified clear loosening in the cement bone interface of the femoral component.There was hardly any bone loss with removal of the implant.The bone was identified to be sclerotic without lytic parts.There was no indication of infection and no evidence of tibial component loosening.The femoral and polyethylene articular surface were removed, however, the polyethylene showed no abnormalities.A health care professional reviewed the provided radiographic images and identified mild osteopenia and radiolucency at the hardware interface of the femoral component and the medial/lateral tibial plateau, suggestive of loosening 23 months post-implantation.The femoral component appeared to be oversized with a gap in between the anterior flange of the femoral component and the femur.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined.Per the instructions for use of the product (87-6204-022-23 rev.A), loosening of the prosthetic knee component is a known potential adverse effect of the total knee arthroplasty procedure.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: PERSONA CRUCIATE RETAINING CEMENTED FEMORAL COMPONENT RIGHT SIZE 5
• 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: 9362408
• Report Number: 3007963827-2019-00333
• Device Sequence Number: 16696602
• Product Code: JWH
• UDI-Device Identifier: 00889024230323
• UDI-Public: (01)00889024230323
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42502605802
• Device Lot Number: 63272495
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention