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

Catalog Number 181142

Device Problems Loss of or Failure to Bond (1068); Incorrect Measurement (1383); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Adept claim letter record received.Awaiting for english translation.Once available this complaint will be updated accordingly.Doi: (b)(6) 2008.Dor: (b)(6) 2015; right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Updated 02 november 2020 re-open.The complaint was re-opened upon receiving further correspondence.The information received did not change the original investigation report.Updated 04 november 2020 re-open.The complaint was re-opened upon receiving the product details.A review of the head product, code 181142, lot 81374 manufacturing records was completed by the manufacturing site, with notification received that: product code 181142, work order (b)(4) was manufactured on the 10 december 2007.12 parts were started and 2 were scrap, leaving 10 manufactured per specification and all raw material met specification.Expiry date: december 2012.Ifu number: pi-400-442.There was 2 parts scrapped with work order (b)(4).There were no deviations found to be associated with work order (b)(4).

Manufacturer Narrative

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.H10 additional narrative: corrected:h6(device codes).Product complaint # (b)(4).Investigation summary
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> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.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.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, d11 and h6 (patient and device code).H6 patient code: no code available (3191) used to capture the device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Appendix c alleges metal wear.This claim is now litigated.Doi: (b)(6) 2008 - dor: (b)(6) 2015 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.E3 initial reporter occupation: lawyer.

• 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 KT22 7BA; UK KT22 7BA
• MDR Report Key: 9676608
• MDR Text Key: 177992727
• Report Number: 1818910-2020-04117
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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: 81374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADEPT® METAL ON METAL CUP 48MM WITH 42MM BORE
• Patient Outcome(s): Required Intervention