MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED ADEPT MODULAR HEAD V40 TAPER 042 OFFSET -4; ADEPT IMPLANT : HIP METAL FEMORAL HEADS

Catalog Number 179242

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Foreign Body Reaction (1868); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 08/29/2019

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.

Event Description

The patient was revised due to loosening and armd.Doi: (b)(6) 2010; dor: (b)(6) 2019; unknown hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device was reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present.Root cause undetermined.Depuy synthes 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.

Manufacturer Narrative

Depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 (device).Product complaint#: (b)(4).Investigation summary
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> the device was reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present.Root cause undetermined.Depuy synthes 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 042 OFFSET -4
• Type of Device: ADEPT IMPLANT : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey KT227 BA; EI KT227BA
• MDR Report Key: 9156308
• MDR Text Key: 161966925
• Report Number: 1818910-2019-107789
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 179242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 11/19/2019; 02/13/2020
• Supplement Dates FDA Received: 11/18/2019; 11/29/2019; 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention