MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign source: china.Concomitant medical products: associated devices: reference number:166941, device name: oxford uni twin-peg femoral sm, lot:6737518, reference number: 154719, device name: oxf uni tib tray sza rm, lot:6681212.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent revision of knee prosthesis due to bearing dislocation in unknown time frame post-op.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records and radiographs were provided and reviewed.Review of the available records identified the following: the right knee prosthesis liner was dislocated on intraoperative exploration, and the medial soft tissue tension was slightly relaxed.The lateral meniscus was found to be good and the anterior and posterior fork ligaments were intact.The size was measured from small to large on a trial mold until the medial and lateral soft tissue tensions were balanced.Type iii anil iodine combined with saline was flushed and a 7mm removable polyethylene liner was re-added.After seeing that the knee joint is stable and there is no obstruction to moving the knee joint, the instruments and dressings are counted correctly.Radiographs final mmi report.Medial compartment hemi arthroplasty with dislocated bearing noted within the suprapatellar bursa.No fracture seen.Possible tibial component subsidence.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15376344
• Report Number: 3002806535-2022-00378
• Device Sequence Number: 5707768
• Product Code: NRA
• UDI-Device Identifier: 05019279786152
• UDI-Public: (01)05019279786152(17)240712(10)6590630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 09/30/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2024
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 6590630
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Prefer Not To Disclose