MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA RM; KNEE ARTHROPLASTY

Model Number	N/A
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation (unavailable by hospital policy).Concomitant medical products: medical product: oxf anat brg rt sm size 3 pma, catalog #: 159568, lot #: 622550.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 765870.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00010, 3002806535-2021-00011.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 that a patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to mechanical loosening was performed on (b)(6) 2020.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to mechanical loosening was performed on (b)(6) 2020.
Additional Manufacturer Narrative
This is a combination product (b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00011-1, 3002806535-2021-00010-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item 159568,1 similar complaints reported with the item 161468 and 2 similar complaint reported with the item 154719 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the root cause of the harms could not be determined with the information currently available, therefore a specific hazard (line) within the risk table cannot be selected.Multiple lines cover hazardous situations of inadequate fixation, sterility and cleanliness related issues, and a harm of loosening.These lines have a maximum severity of 4 (necessitates surgical intervention), and a maximum occurrence of 3 (1 in 100 to 1 in 1000).Because the information provided does not detail which implant was effected with mechanical loosening an occurrence rate has been calculated for both the femoral and tibial component.Occurrence rate assessment for item 161468.(b)(6) 2017 to (b)(6) 2020: 15193 items sold.Number of similar complaints identified: 1 (including initiating complaint).Occurrence ratio: 1 : 15193.Occurrence rate assessment for item 154719.(b)(6) 2017 to (b)(6) 2020: 17086 items sold.Number of similar complaints identified: 2 (including initiating complaint).Occurrence ratio: 1 : 8543.An occurrence rate has not been calculated for the oxford bearing 159568 / lot 622550 as it is not related to this event (loosening).If further information regarding the root cause of the reported event or reason for revision are provided, the risk will be re-assessed.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: OXF UNI TIB TRAY SZA RM
• Common Device Name: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11147088
• Report Number: 3002806535-2021-00012
• Device Sequence Number: 14326277
• Product Code: NRA
• UDI-Device Identifier: 05019279388851
• UDI-Public: 05019279388851
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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 Model Number: N/A
• Device Catalogue Number: 154719
• Device Lot Number: 147350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/15/2021
• 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: 71 YR