MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ A RM SIZE A RM; OXFORD CEMENTLESS TIBIAL TRAYS

Model Number N/A

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: oxf anat brg rt sm size 5 pma; item# 159570; lot# 7150577.Oxf pks c/less fem cocr sz sml pc/ha; item# 154925; lot# 7349116.G2 - foreign: japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient who underwent unicompartmental knee arthroplasty experienced a tibia bone fracture postoperatively.The implants remain in the patient's body.The surgeon commented that the tibial cementless base plate is larger than the actual dimensions indicated on the label, and the cementless base plate with a larger dimension than indicated may have been used, resulting in a tibial fracture.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product remains implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified initial anatomic alignment of the right knee medial unicompartmental arthroplasty complicated by a periprosthetic fracture of the medial tibia with implant loosening and subsidence.Osteopenia.Initial fit and alignment were maintained.2 month imaging demonstrates tibial implant loosening and subsidence with malalignment secondary to a tibial periprosthetic fracture.Bone quality is osteopenic.The tibial implant is loose with subsidence and malalignment secondary to the periprosthetic fracture as noted.There is a medial tibial periprosthetic fracture.The degree of osteopenia present could contribute to a fracture in this patient.With the available information, a definitive root cause could not be determined however, osteopenia could be a contributing factor.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.

• Brand Name: OXF UNI CMNTLS TIB SZ A RM SIZE A RM
• Type of Device: OXFORD CEMENTLESS TIBIAL TRAYS
• 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: 17859354
• MDR Text Key: 324774989
• Report Number: 3002806535-2023-00335
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354823
• UDI-Public: (01)00887868354823(17)321122(10)7364994
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166846
• Device Lot Number: 7364994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose