MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN RECAP RESURFACING HEAD; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 09/12/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported by the patient that she underwent an initial hip replacement surgery.Subsequently, a revision procedure was performed due to femoral neck fracture.The recap resurfacing hip system was converted into recap magnum total hip.A 42 mm head with taperloc hip stem were implanted.Recap acetabular cup remained in situ.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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 by the patient that she underwent an initial hip replacement surgery.Subsequently, a revision procedure was performed due to femoral neck fracture.The recap resurfacing hip system was converted into recap magnum total hip.A 42 mm head with taperloc hip stem were implanted.Recap acetabular cup remained in situ.

• Brand Name: UNKNOWN RECAP RESURFACING HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8938840
• MDR Text Key: 155786714
• Report Number: 3002806535-2019-00698
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/21/2019
• 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