MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED POSTERIOR STABILIZED (PS); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: articular surface fixed bearing constrained posterior stabilized (cps) right 10 mm height use with tibia sizes c-d / ps femur sizes 6-9 catalog # 42522600510, lot # 64461648; tibia cemented 5 degree stemmed right size d catalog # 42532006702, lot # 64355617; all poly patella cemented 35 mm diameter catalog # 42540000035 ,lot # 64374887; stem extension tapered cemented 14 mm diameter +30 mm length catalog # 42557000114, lot # 64832711; articular surface fixed bearing constrained posterior stabilized (cps) left 12 mm height use with tibia sizes e-f / ps femur sizes 10-11 catalog # 42512600812, lot # 63904814; natural tibia cemented 5 degree stemmed left size e catalog # 42532007101, lot # 64367521; all poly patella cemented 32 mm diameter catalog # 42540000032, lot # 64367722; stem extension tapered cemented 14 mm diameter +30 mm length catalog # 42557000114, lot # 64359223; refobacin bone cement r 1x40-3 3 catalog # 30039400013, lot # a941bk1904; hip kit catalog # 00515048200 ,lot # 64796937; reciprocating saw blade zimmer biomet recip catalog # 12076100ur1, lot # 348875; oscillating saw blade zimmera /synthesa catalog # 19090127af1 ,lot # 372069.Report source: (b)(6).Device evaluated by mfr: customer has indicated that the product will not be returned because it remains implanted.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 patient is experiencing pain and loosen implant three months post implantation.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.Reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates loosening and periprosthetic fracture on both knee femur.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 FEMUR CEMENTED POSTERIOR STABILIZED (PS)
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12590795
• Report Number: 3007963827-2021-00228
• Device Sequence Number: 12265561
• Product Code: JWH
• UDI-Device Identifier: 00889024228818
• UDI-Public: (01)00889024228818(17)290430(10)64230408
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 42500006801
• Device Lot Number: 64230408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Female