MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 3 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.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00446, 3002806535-2021-00447.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that the patient was seen in clinic on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4).Per visit note from (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed nsaids and will be seen for a follow-up on (b)(6) 2021.
Event or Problem Description
It was reported, that: patient was seen in clinic on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4).Per visit note from on (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed nsaids and will be seen for a follow-up on (b)(6) 2021.Addi on (b)(6) 2021:.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: no product was returned; visual and dimensional evaluations could not be performed.This device is used for treatment.No compatibility issues were noted.Device history record (dhr) review was unable to be performed as item#: 161474, lot#: 2409869 is missing and listed in capa: ca-03772 missing mhrs.Review of the device history records for item#: 159575, lot#: 533550 and item#: us166575, lot #: 3050471 identified no related deviations or anomalies during manufacturing related to the reported event.A review of the complaints database for 3 years prior to the notification date has identified the following: (6) similar complaints for item#: 159575 (including initiating complaint).There were (0) additional complaints against the lot#: 533550.(2) similar complaints for item#: 161474 (including initiating complaint).There were (0) additional complaints against the lot#: 2409869.(1) similar complaints for item#: us166575 (including initiating complaint).There were (0) additional complaints against the lot#: 3050471.The clinical study patient was seen on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4): in the radiographs from the 5-year follow-up the fit and position of all components appear to be adequate in accordance with the guidelines in the oxford surgical technique.Per visit note from on (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed treatment.The root cause of the reported adverse event could not be determined with the available information.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and further investigated.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00446-1, 3002806535-2021-00447-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG RT MD SIZE 3 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: 12638097
• Report Number: 3002806535-2021-00445
• Device Sequence Number: 15393422
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: 05019279786213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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 Expiration Date: 03/24/2019
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 533550
• 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: 10/08/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 76 KG