MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD FEMORAL COMPONENT; KNEE PROTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

Complaint handling # (b)(4).Concomitant medical products: medical product: unknown bearing component, catalog #: unknown, lot #: unknown medical product: unknown tibial component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00004 3002806535-2020- 00006.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

T was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D11: medical product: unk oxford tibial component, catalog #: unknown, lot #: unknown medical product: unk oxford bearing, catalogue#: unknown, lot#: unknown multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00006-1, and 3002806535-2020-00004-1.Biomet uk ltd have attempted to contact the sales representative, however, we have not been able to retrieve any further information relevant to this complaint.The product has not been returned to biomet uk ltd for evaluation, therefore, a thorough investigation has not been possible.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9562270
• MDR Text Key: 174104575
• Report Number: 3002806535-2020-00005
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• 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: UNK OXFORD FEMORAL COMPONENT
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE -H10
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 36 YR