MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEX HEADED SCREW 3.5 MM HEX 48 MM LENGTH; 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); Bursitis (4832)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp-0933548 customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42504605802 persona femur cemented standard right size 5 lot# 64890399 42540200029 persona all-poly patella cemented 29 mm dia lot# 64843582 42560007514 persona stem extension tapered cemented 14 mm dia +75mm l lot# 65042512 42542006702 persona tibia fixed cemented right size d lot# 64960944 42522800410 persona articular surface fixed bearing (cck) right 10mm lot# 64751747 42560007514 persona stem extension tapered cemented 14 mm dia +75mm l lot# 65042512 unk stryker cement x 4.
Event or Problem Description
It was reported a patient had an initial right total knee arthroplasty followed by a revision 7 years later due to aseptic loosening.Subsequently, the patient began to experience pain over the pes bursa and was initial prescribed nsaids and physical therapy for pes anserinus bursitis.The patient received a cortisone injection sixteen months post revision.All implants remain in place and at the two-year follow-up, reports no pain.
Additional Manufacturer Narrative
Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The initial report should be voided.Item was not implanted.
Event or Problem Description
Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The initial report should be voided.Item was not implanted.

• Brand Name: HEX HEADED SCREW 3.5 MM HEX 48 MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19139798
• Report Number: 0001822565-2024-01331
• Device Sequence Number: 15811965
• Product Code: LXH
• UDI-Device Identifier: 00889024563193
• UDI-Public: (01)00889024563193(17)300630(10)64709940
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: 00590103548
• Device Lot Number: 64709940
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White