MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 6 PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Information (3190)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Associated products only: medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: 517270.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 677280.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a total knee arthroplasty.Subsequently, the patient was revised due to dislocation.An oxford bearing was removed due to dislocation.The bearing was removed three days after dislocation.Upon removal the surgeon noticed unusual "pitting" and wear along the underside of the poly.This was a cause for concern considering the patient was only 6 months post op.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Product has been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.A 6 mm oxford meniscal bearing was revised after 6 months and 22 days due to dislocation.The available relevant manufacturing history record indicate that the items were manufactured in accordance with the applicable specifications.The revised meniscal bearing shows extensive pitting, deep scratches and polishing on the inferior articulating surface.Scratches and polishing are also observed on the superior articulating surface, as well as damage to the medial anterior corner of the component.The root cause of the reported bearing dislocation and damage cannot be determined from the provided information, however third body debris, impingement and patients activity (yoga) may have been contributing factors to the early failure of the implant.The available mhr reviews indicate that the products were most likely conforming to design specification when they left zimmer biomet control.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.Failure analysis report concludes: a 6 mm oxford meniscal bearing was revised after 6 months and 22 days due to dislocation.The revised meniscal bearing shows extensive pitting, deep scratches and polishing on the inferior articulating surface.Scratches and polishing are also observed on the superior articulating surface, as well as damage to the medial anterior corner of the component.The root cause of the reported bearing dislocation and damage cannot be determined from the provided information, however third body debris, impingement and patients activity (yoga) may have been contributing factors to the early failure of the implant.The reported event states revision due to bearing dislocation.In the risk file, dislocation is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: s-3 prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported the patient underwent a total knee arthroplasty.Subsequently, the patient was revised due to dislocation.

• Brand Name: OXF ANAT BRG RT MD SIZE 6 PMA
• Common Device Name: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10492831
• Report Number: 3002806535-2020-00400
• Device Sequence Number: 2390926
• Product Code: NRA
• UDI-Device Identifier: 05019279786244
• UDI-Public: 05019279786244
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P01004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 159578
• Device Lot Number: 160830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR