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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/08/2022

Event Type  Injury  

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 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.

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 Description

No further event information available at the time of this report.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 PMA
• Type of Device: 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
• MDR Text Key: 299452047
• Report Number: 3002806535-2022-00378
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786152
• UDI-Public: (01)05019279786152(17)240712(10)6590630
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P010014
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Prefer Not To Disclose