MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD SIZE D TIBIA; PROSTHESIS, KNEE

Catalog Number UNKNOWN

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

Patient Problem Muscle/Tendon Damage (4532)

Event Type  Injury  

Event Description

The avulsion fracture occurred during the range of motion testing and is a risk when the acl is intact.Since this was an intraoperative complication that required additional intervention outside of the planned procedure (screw placement), it would be considered a procedure-related issue.Due diligence is completed for this complaint; to date whatever additional information received has been captured in the complaint.

Manufacturer Narrative

(b)(4).D10- medical products: item#: unknown; lot#: unknown; item name: unknown oxford medium femur; item#: unknown; lot#: unknown; item name: unknown oxford 4mm mobile bearing; item#: unknown; lot#: unknown; item name: unknown cement; item#: unknown; lot#: unknown; item name: unknown 4.0mm cancellous screw.D10 -therapy date: unknown.G2-foreign- japan.G2-literature- journal article.Intraoperative avulsion fracture of the intercondylar eminence in oxford mobile-bearing unicompartmental knee arthroplasty: case report.Akira saitoh, takafumi hiranaka, akihiko arimoto, atsuki tanaka, yoshihito suda, motoki koide, takaaki fujishiro, koji okamoto (2022) https://doi.Org/10.1016/j.Knee.2022.11.017.H3-other: device evaluation could not be performed as part# and lot# unknown.Also device location is unknown.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.An avulsion fracture is the tearing of the tendon off of the insertion point of the bone.The intraop avulsion fracture required additional intervention not in the original treatment plan.Therefore, this event is considered a serious injury.With the available information, a definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00324, 3002806535 - 2023 - 00327.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 SIZE D TIBIA
• Type of Device: PROSTHESIS, KNEE
• 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: 17842387
• MDR Text Key: 324562128
• Report Number: 3002806535-2023-00325
• Device Sequence Number: 1
• Product Code: NRA
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 88 YR
• Patient Sex: Male