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

Catalog Number 159578

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) d10: associated products: oxf twin-peg cmntd fem md pma; item# 161469, lot# 475010.Oxf uni tib tray sz d rm pma; item# 154725; lot# 168030.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a revision surgery to swap knee bearing approximately three years post initial implantation due to bearing dislocation while bending over in the yard.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Medical records were provided and reviewed by a health care professional.The review identified that radiographs from initial implantation to 8 week follow up showed well fixed and well positioned implants.The patient's long term goal was met approximate 2 months post initial surgery, of functional arom to tolerate full bend and partial squat with minimal pain.Subsequently the patient's bearing was revised where the medical notes reports general anesthesia, previous incision utilized clear translucent fluid was noted with no suspicion of an infectious process, polyethylene bearing explanted, which had been dislocated and was in the suprapatellar pouch, good alignment and stability, no intraoperative complications reported.An unknown 8mm bearing was implanted.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG RT MD SIZE 6 PMA
• Type of Device: KNEE PROSTHESIS
• 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: 17874896
• MDR Text Key: 324960773
• Report Number: 3002806535-2023-00339
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786244
• UDI-Public: (01)05019279786244(17)240831(10)539000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 159578
• Device Lot Number: 539000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 11/15/2023
• Supplement Dates FDA Received: 10/27/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 117 KG