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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Reaction (2414); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi : (b)(4).Concomitant medical products: item#: 42502606001; femur cemented (cr) standard left size 6; lot#:63819910, item#: 42532006701;tibia cemented 5 degree stemmed left size d; lot#:63949792, item#: 42512100414; articular surface medial congruent (mc) left 14 mm ; lot#:63788567.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00240, 3007963827 - 2020 - 00241, 3007963827 - 2020 - 00242.
Event or Problem Description
It was reported that patient underwent left total knee arthroplasty approximately 2 years ago.Subsequently, patient experienced pain and swelling since her procedure.Patient underwent manipulation under anesthesia three months after initial procedure, where the surgeon went in and bent and broke things lose in her knee, this did not help.Patient underwent a second manipulation 2 months after her first mua, which was orthoscopicly to remove scar tissue, this did not help either and the scar tissue grew back worse than before.Patient cannot bear weight and continues to walk with a cane.Patient has undergone allergy testing and is highly reactive to nickel.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a healthcare professional.Review of the available records identified the following: patient has a known nickel allergy.The root cause of the reported issue of allergic reaction is attributed to patient condition.The adhesions/scar tissue is a procedure related complication and therefore no device failure detected.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
No further event information available at the time of this report.

• 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: 10586419
• Report Number: 0002648920-2020-00432
• Device Sequence Number: 2977370
• Product Code: MBH
• UDI-Device Identifier: 00889024247635
• UDI-Public: (01)00889024247635
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000032
• Device Lot Number: 64239743
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 73