MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA HEAD 12/14 36X0; HIP ARTHROPLASTY

Model Number N/A

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical products: medical product: biolox delta cer lnr 36mm e, catalog #: 110003634, lot #: 6548686, medical product: g7 pps ltd acet shell 52e, catalog #: 010000663, lot #: 6629812, medical product: ml taper sz12.5 std offset, catalog #: 00-7711-012-00, lot #: 64145181.(b)(6).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 right total hip arthroplasty.Subsequently, the patient reported pain and the feeling of the hip locking.An x- ray identified that the ceramic parts are fractured and loose.Revision surgery is planned for (b)(6) 2020.This complaint reports the implant fractured.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current manufacturer.This event will be reported by medwatch facility winterthur ch 9613350.

Event Description

Ceramics fractured.

• Brand Name: BIOLOX DELTA HEAD 12/14 36X0
• Type of Device: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9897272
• MDR Text Key: 187570526
• Report Number: 3002806535-2020-00191
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192416
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• 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: 00-8775-036-02
• Device Lot Number: 2989510
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2020
• 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
• Patient Age: 60 YR