MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED ADEPT MODULAR HEAD V40 TAPER 050 OFFSET +0; ADEPT IMPLANT : HIP METAL FEMORAL HEADS

Catalog Number 179350

Device Problem Separation Problem (4043)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

On (b)(6) 2019 the patient was revised due to discomfort.X-ray revealed disassociation between femoral head and stem trunnion.Doi: (b)(6) 2009; dor: (b)(6) 2019: right hip.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ADEPT MODULAR HEAD V40 TAPER 050 OFFSET +0
• Type of Device: ADEPT IMPLANT : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park,; randall; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 9075429
• MDR Text Key: 162598743
• Report Number: 1818910-2019-104867
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

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 Catalogue Number: 179350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention