MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED ADEPT® METAL ON METAL RESURFACING HEAD 42MM; ADEPT IMPLANT : HIP METAL FEMORAL HEADS

Catalog Number 181142

Device Problem Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 02/15/2010

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

Email notification record received.Email notification alleges pain, malalignment and neck fracture.Doi: (b)(6) 2009; dor: (b)(6) 2010; unkown.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.No device was received.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.Investigation methods: was patient affected: yes.Device history reviewed: yes.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.A review of complaint databases did not identify any anomalies.A review of manufacturing records did not identify any anomalies.20 parts were manufactured and placed into stock on jul 2006.2 devices were scrapped and one returned to supplier for rework.It should be noted that no device was returned.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history lot : a review of manufacturing records did not identify any anomalies.20 parts were manufactured and placed into stock on jul 2006.2 devices were scrapped and one returned to supplier for rework.Device history batch : null.Device history review : null.

• Brand Name: ADEPT® METAL ON METAL RESURFACING HEAD 42MM
• Type of Device: ADEPT IMPLANT : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey KT227 BA; UK KT227BA
• MDR Report Key: 9117896
• MDR Text Key: 161962864
• Report Number: 1818910-2019-105908
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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: 181142
• Device Lot Number: 065681
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention