MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED MITCH TRH¿ MODULAR HEAD 50MM +8MM NECK; MITCH TRH IMPLANT : HIP ACETABULAR METAL HEMI

Catalog Number OEMSYKMMH99881850

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 03/29/2019

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

Mitch revision; left hip; reason for revision: dislocation.Doi: unknown; dor: (b)(6) 2019; left hip.

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 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.Product complaint # (b)(4).The devices were 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 : a review of manufacturing records of lot fm067801 did not identify any anomalies.24 parts were manufactured and placed into stock on oct 2006.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MITCH TRH¿ MODULAR HEAD 50MM +8MM NECK
• Type of Device: MITCH TRH IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey KT227 BA; UK KT227BA
• MDR Report Key: 9262864
• MDR Text Key: 177266768
• Report Number: 1818910-2019-113120
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OEMSYKMMH99881850
• Device Lot Number: FM067801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR