MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 8.5CM SEG ELLIPT FMRL-RT; PROSTHESIS, KNEE

Catalog Number 150495

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 05/12/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial total knee arthroplasty.Post-operatively, a screw which connected the femoral component and stem backed out.Approximately four years post-implantation, the patient underwent revision surgery to replace the screw.The screw was exchanged without complication and the femoral component and stem remain implanted.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Concomitant medical product: oss porous im stem 12.5 x 150: catalog#150391, lot#930680; oss non-mod tib plate short 67: catalog#150417, lot#702220; oss tibial poly bearing 14mm: catalog#150411, lot#790370; oss poly femoral bushings: catalog#150477, lot#302680; oss axle: catalog#150480, lot#733890; oss poly lock pin: catalog#150478, lot#813920; oss poly tibial bushing: catalog#150476, lot#297550; oss reinforced yoke: catalog#150493, lot#169750.Report source: foreign: (b)(6) multiple mdr reports have been filed for this event.Please see associated report: 0001825034-2022-01368.Customer has indicated that the product will not be returned to zimmer biomet for evaluation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual and dimensional evaluations of the product could not be performed as no product was returned.Photograph provided shows disassociated screw with wear consistent with usage of device.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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 Description

No further event information at time of this report.

• Brand Name: OSS 8.5CM SEG ELLIPT FMRL-RT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14654034
• MDR Text Key: 294869986
• Report Number: 0001825034-2022-01369
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 150495
• Device Lot Number: 739670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose