MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLES FEM SZ XL; OXFORD CEMENTLESS FEMORALS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: 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: 3002806535-2021-00366 and 3002806535-2021-00368.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to pain in the lateral component was performed on (b)(6) 2021.Drs assessment was he may have "overstuffed" the medial compartment.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.X-ray review could not be performed due to low quality images.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 complaint reported with the item 159561,1 complaint reported with the item 154928 and 2 complaints reported with the item 166576 (including the initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00366-1, 3002806535-2021-00368-1.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 Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to pain in the lateral component was performed on (b)(6) 2021.Drs assessment was he may have overstuffed the medial compartment.

• Brand Name: OXFORD PH3 CEMENTLES FEM SZ XL
• Type of Device: OXFORD CEMENTLESS FEMORALS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12405616
• MDR Text Key: 269417957
• Report Number: 3002806535-2021-00367
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154928
• Device Lot Number: 3871099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention