MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Synovitis (2094); Metal Related Pathology (4530)

Event Date 07/08/2022

Event Type  Injury  

Event Description

It was reported that the patient was revised due to implant fracture.

Manufacturer Narrative

(b)(4).Foreign: germany.Medical product unknown.Oxford twin peg fem medium.Catalog#: unknown, lot#:unknown.Medical product unknown.Oxford tib catalog#: unknown.Lot#:unknown.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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint history review cannot be performed without product identification.Medical records were not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Investigation is still ongoing.Operation notes from the revision surgery were provided.Review of the available records identified the following: inlay fracture which caused metal on metal friction.Tibial and femoral bones were found to be massively softened with metallosis.Revision undertaken of the oxford components and replaced with a competitor's posterior stabilised full knee prosthesis.

Event Description

It was reported that, the patient experienced a bearing fracture with inset slide on the right side which caused metal on metal friction, approximately eight (8) years post-op.Tibal and femoral bones were found to be massively softened with metallosis.A synovectomy was performed to treat the massive synovitis.A revision of the oxford components was performed.

Event Description

It was reported that the patient was revised due to implant fracture and loosening in the right knee, approximately eight (8) years post-op.During revision massive synovitis and metalosis was found.

Manufacturer Narrative

Cmp(b)(4).This follow-up report is being submitted to relay additional information.Investigation is still ongoing.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product returned or pictures provided, patient consent has not been granted.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.Operation notes from the revision surgery were provided.Review of the available records identified the following: inlay fracture which caused metal on metal friction.Tibial and femoral bones were found to be massively softened with metallosis.Revision undertaken of the oxford components and replaced with a competitor's posterior stabilised full knee prosthesis.Pre and post revision radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: impression:- initial imaging demonstrating osteolysis along the medial unicompartmental arthroplasty components with subluxation, malalignment, and metal-on-metal contact as noted.Subsequent revision to a total knee system with anatomic alignment.On the initial two sets of images, there was peri-implant osteolysis and suspected implant loosening.Malalignment was present as noted with interval worsening of alignment.Bone quality was osteopenic on all images.There was abnormal radiolucency reflecting osteolysis with suspected implant loosening and progressive malalignment as noted.The degree of osteolysis along the implants and the progression of malalignment as well as the metal-on-metal implant contact as described would necessitate revision of the arthroplasty.Furthermore, it has not been possible to establish the hospital which performed the primary surgery as no patient notes were provided to the surgeon who performed the revision surgery.Due to this, it has not been possible to establish the item and lot numbers of the revised parts and it has not been possible to obtain post primary radiographs.The revised parts have not been returned for evaluation because the patient has not provided consent.A definitive root cause of the bearing fracture cannot be determined with the information available as post primary radiographs are not available, patient notes are not available from the primary surgery and the product is not available for assessment.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: UNKNOWN OXFORD BEARING
• Type of Device: PROSTHESIS, KNEE
• 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: 15197804
• MDR Text Key: 297581429
• Report Number: 3002806535-2022-00350
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN OXFORD BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/31/2022; 11/11/2022; 12/12/2022; 02/09/2023
• Supplement Dates FDA Received: 09/02/2022; 12/06/2022; 12/15/2022; 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• 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): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 78 KG