MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 5 PMA; KNEE PROSTHESIS

Catalog Number	159584
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated products: oxford ph3 cementless fem sz l; item# 154927; lot# 7399003.Oxf uni cmntls tib sz e rm; item# 166579; lot# 7302023.G2 - foreign: australia.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that six months post initial right knee arthroplasty, the patient had to undergo a revision surgery for a dislocated bearing.Dislocation occurred while patient was riding a bike.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.Visual examination of the provided pictures identified an explanted oxford bearing.Nothing further could be gained from the photos.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided but were not sent for radiologist review as they are not dated.They do however confirm a dislocated bearing.With the available information, a definitive root cause could not 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 LG SIZE 5 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: 18083842
• Report Number: 3002806535-2023-00375
• Device Sequence Number: 7916412
• Product Code: NRA
• UDI-Device Identifier: 05019279786305
• UDI-Public: (01)05019279786305(17)270616(10)7269022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/19/2023

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: Lay User/Patient
• Device Catalogue Number: 159584
• Device Lot Number: 7269022
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 108 KG