MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 5 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: the patient underwent an initial knee arthroplasty on (b)(6) 2013.Subsequently, the patient had pain and instability which required a poly exchange to a thicker bearing which was performed on an unknown date.Patient outcome: revision.No delay.
Additional Manufacturer Narrative
(b)(4).This follow-up document is being submitted to relay supplemental information.D10: medical product: oxford pks c/less femoral cocr sz small pc/ha catalogue number: 154925.Lot number: unknown.Medical product: oxford uni c/less tibial tray rm b catalogue number: 166573 lot number: unknown.Medical product: oxford pks anat men brg uhmwpe rt sml sz 5 catalogue number: 159570.Lot number: unknown.Medical product: blade kit catalogue number: 11-3585.Lot number: unknown.Supplemental information acquired: explant date.Associated products.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.
Event or Problem Description
It was reported, that: a patient underwent an initial knee arthroplasty on (b)(6), 2013.Subsequently, the patient had pain and instability which required a poly exchange to a thicker bearing which was performed on an unknown date.Patient outcome: revision.No delay.28 feb 2022 addi surgeon - dr (b)(6) initial procedure performed - (b)(6) hospital no lot numbers available original implants are listed below: 154925 oxford pks c/less femoral cocr sz small pc/ha 166573 oxford uni c/less tibial tray rm b 159570 oxford pks anat men brg uhmwpe rt sml sz 5 11-3585 blade kit the original surgeon happened in 2013 and no records were available at the time of revision.Date of revision was (b)(6) 2022 were there any patient-specific indications that could have led to the revision? no, the surgeon did not believe so.No other implants were removed or revised, unfortunately, no lot number was available.Explanted implant not returned due to hospital policy.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided.Review of the device history records could not be carried out as the lot number is unknown.Review of complaint history identified 6 additional similar complaints for the reported item.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to reported event.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and product has not been returned for evaluation.The root cause of the reported event cannot be determined with the information provided.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text : device not returned.
Event or Problem Description
It was reported, that: a patient underwent an initial knee arthroplasty on (b)(6) 2013.Subsequently, the patient had pain and instability which required a poly exchange to a thicker bearing which was performed on an unknown date.Patient outcome: revision.No delay.

• Brand Name: OXF ANAT BRG RT SM SIZE 5 PMA
• Common Device Name: OXFORD HXLPE BEARINGS
• 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: 13497870
• Report Number: 3002806535-2022-00062
• Device Sequence Number: 11938385
• Product Code: NRA
• UDI-Device Identifier: 05019279786169
• UDI-Public: 05019279786169
• 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: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2022

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: 159570
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 03/07/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/03/2022; 03/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 85 KG