MAUDE Adverse Event Report: BIOMET UK LTD. OXF PH3 CEMENTLESS TIB SZ D RM; KNEE PROSTHESIS

Model Number N/A

Device Problem Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: medical product: unk oxford bearing catalog #: unknown lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00631.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Revision due to dislocation.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The possible cause might be femoral component too small and not balanced, as reported by the clinical department.However, the root cause could not be confirmed as we have not received the product or x-rays.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent an initial knee replacement procedure.Subsequently, due to the femoral component being too small the patient experienced repeated dislocation of the bearing.Revision of the bearing and tibial component were performed.

• Brand Name: OXF PH3 CEMENTLESS TIB SZ D RM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8830269
• MDR Text Key: 152311314
• Report Number: 3002806535-2019-00632
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00501927939009
• UDI-Public: 0501927939009
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2013
• Device Model Number: N/A
• Device Catalogue Number: 154920
• Device Lot Number: 712254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 08/28/2019
• 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