MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 32 MM DIAMETER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#:42522400412;art surface fb (ps) right 12 mm height;lot#: 63516313, item#:42500605802;femur cemented (ps) standard right size 5;lot#: 63897803, item#:42532006402;tibia cemented 5 degree stemmed right size c; lot#: 63917325, item#:unknown;unknown bone cement;lot#: unknown.Reported event was confirmed by review of medical records.No product was returned or pictures provided as it was discarded; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2021 no evidence for loosening or infection on bone scan; (b)(6) 2021 patient reports pain, swelling with activities that radiates, night pain, and throbbing despite bracing, pr and nsaids, patellar loosening with bone reabsorption; v 2021 synovial fluid clear yellow and healthy sent for culture, no infection, no loosening of femur, tibia, patella component removed easily with cement remaining in 2 inferior lug holes, superior lug hole was soft tissue only, cement remained in inferior holes due to increased risk of patella fracture, no fracture noted, poor bone quality.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Initial right total knee arthroplasty three years ago, subsequently revised two months ago due to pain, swelling, night pain, and throbbing.The patella component removed, due to loosening, but it was not replaced due to poor bone quality, and poly exchanged without complications.

• Brand Name: ALL POLY PATELLA CEMENTED 32 MM DIAMETER
• 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: 12433452
• Report Number: 0002648920-2021-00254
• Device Sequence Number: 3593925
• Product Code: MBH
• UDI-Device Identifier: 00889024247635
• UDI-Public: (01)00889024247635(17)260531(10)64033931
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 42540000032
• Device Lot Number: 64033931
• 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: 08/17/2021
• Initial Report FDA Received Date: 09/07/2021
• 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
• Patient Weight: 68