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

Model Number	159541
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign: (b)(6).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 the inlay (bearing) fractured after cementless knee implantation in 2008, without adequate trauma.No remedial action has been reported.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 and/or corrected information.D10: associated products: item number: 154925, item name: oxford ph3 cementless fem sz s, item lot: unknown item number: 154915, item name:oxf ph3 cementless tib sz b lm, item lot: unknown no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product lot number being provided.Review of complaint history identified additional similar complaints for the reported item.As the lot number is unknown, an additional review could not be performed.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Device is used for treatment.Radiographs were provided and reviewed by a health care radiologist.Impressions are narrowing of the medial compartment noted on images acquired at and after 08/09/2021 which is suggestive of nonspecific disruption or wear of the polyethylene lining in this region.This results in narrowing of the medial compartment joint space.Medical records were not provided.With the available information, 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
It was reported that the patient underwent a bearing revision due to fracture without adequate trauma, approximately 15 years post-op.

• Brand Name: OXF ANAT BRG LT 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 ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16442278
• Report Number: 3002806535-2023-00048
• Device Sequence Number: 5417018
• Product Code: NRA
• UDI-Device Identifier: 05019279785872
• UDI-Public: (01)05019279785872
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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 Model Number: 159541
• Device Catalogue Number: 159541
• Device Lot Number: UNKNOWN
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female