MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD; 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); Unspecified Infection (1930)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42532007502 - tibia cemented 5 degree stemmed right size f - 64658695.42522000512 - articular surface fixed bearing cruciate retaining (cr) right 12 mm height - 64171808.Unknown - unknown 35mm patella - unknown.Report source: foreign country: (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 3007963827-2021-00154.
Event or Problem Description
It was reported that the patient underwent an initial right knee arthroplasty.Subsequently, the patient was revised approximately 10 months later as there was a possible infection leading to loosening of the femoral component and possibly the tibial component.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records could not confirm the presence of infection in the patient.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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00154-1; 0001822565-2021-03317.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD
• 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: 12197557
• Report Number: 3007963827-2021-00153
• Device Sequence Number: 1480575
• Product Code: MBH
• UDI-Device Identifier: 00889024230385
• UDI-Public: (01)00889024230385(17)300331(10)64619472
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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 Model Number: N/A
• Device Catalogue Number: 42502606402
• Device Lot Number: 64619472
• 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: 06/28/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 101 KG