MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA STEMMED CEMENTED TIBIAL COMPONENT RIGHT SIZE G; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pain (1994); Scar Tissue (2060); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona fixed bearing ultracongruent articular surface 10mm right catalog #: 42522200610 lot #: 62593330, persona cemented cruciate retaining standard femoral component right size 9 catalog #: 42502606602 lot #: 62670280.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a right knee arthroplasty revision to address tibial component loosening and increasing pain approximately five (5) years post-operatively.Initial operative notes did not note any intraoperative complications.Revision operative notes noted that the medial tibial plateau of the tibial component was loose.Upon removal of the tibial component, the tibia medial side had bone that was reportedly soft and mushy.Extensive scar tissue was found involving the patella and medial proximal tissue.The femoral component was noted to be well-fixed, however, the tibial component could not be removed without removal of the femoral component, so the surgeon removed all components except the patella.No intraoperative complications were noted.Attempts have been made, however, no additional information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 STEMMED CEMENTED TIBIAL COMPONENT RIGHT SIZE G
• 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
• MDR Report Key: 12449215
• Report Number: 0002648920-2021-00235
• Device Sequence Number: 3578601
• Product Code: JWH
• UDI-Device Identifier: 00889024471108
• UDI-Public: (01)00889024471108(17)260131(10)63248376
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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 Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42532007902
• Device Lot Number: 63248376
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention