MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 4 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 its location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00455, 3002806535-2021-00456.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device location unknown.
Event or Problem Description
It was reported, that the patient was seen on (b)(6) 2021 and complained of pain due to a snapping/popping when working out in the gym from 2 years ago.This issue was reported in (b)(4).Per visit notes from (b)(6) 2021, implants are in good position.Diagnosis of right meniscal injury was found and patient was advised to get an mri done for further evaluation.Patient refused the mri since his symptoms were mild and will continue taking otc anti-inflammatory meds.Patient is not scheduled for a follow-up at this time.
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.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A review of the complaints database for 3 years prior to the notification date has identified the following: (4) similar complaints for item #159583 (including initiating complaint and (1) linked complaint for same patient).There were (2) additional complaints against the lot #377130 (including initiating complaint and (1) linked complaint for same patient).(3) similar complaints for item #us166577(including initiating complaint and (1) linked complaint for same patient).There were (2) additional complaints against the lot #3050481 (including initiating complaint and (1) linked complaint for same patient).(7) similar complaints for item #161475 (including initiating complaint and (1) linked complaint for same patient).There were (3) additional complaints against the lot #2407054 (including initiating complaint and (1) linked complaint for same patient).The clinical study patient was seen on (b)(6) 2021 and complained of pain due to a snapping/popping which onset (b)(6) 2019, after using an elliptical bike at the gym.This issue was first reported in (b)(4).Per visit note from (b)(6) 2021, implants are in good position.Diagnosis of right meniscal injury was found and patient was advised to get an mri done for further evaluation.The patient refused the mri since his symptoms were mild and will continue taking otc anti-inflammatory meds.Patient is not scheduled for a follow-up at this time.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: 3002806535-2021-00455-1.3002806535-2021-00456-1.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.
Event or Problem Description
8 oct 2021 it was reported, that: patient was seen on (b)(6) 2021 and complained of pain due to a snapping/popping when working out in the gym from 2 years ago.This issue was reported in (b)(4).Per visit note from (b)(6) 2021, implants are in good position.Diagnosis of right meniscal injury was found and patient was advised to get an mri done for further evaluation.Patient refused the mri since his symptoms were mild and will continue taking otc anti-inflammatory meds.Patient is not scheduled for a follow-up at this time".Addi 27 oct 2021: please see attached radiographs.

• Brand Name: OXF ANAT BRG RT LG SIZE 4 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: 12670923
• Report Number: 3002806535-2021-00454
• Device Sequence Number: 17196549
• Product Code: NRA
• UDI-Device Identifier: 05019279786299
• UDI-Public: 05019279786299
• 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: 09/02/2019
• Device Model Number: N/A
• Device Catalogue Number: 159583
• Device Lot Number: 377130
• 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: 10/21/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 102 KG