MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 14X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1976-14-140
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Product details: reclaim stem 14mm x 140mm straight stem.1976-14-140 lot h64477 date: 17/6/2019.Issue: femoral canal prepared as per surgical technique.Above femoral stem implanted as per surgical technique.When surgeon went to remove taper protector sleeve it would not disengage.Proximal aspect of sleeve eventually broke leaving distal part in situ.Stem then had to be removed and another implant opened and implanted in its place.Case length was extended by approx 15 minutes.
Additional 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).Investigation summary: the device associated with this report was not returned.The report has been confirmed using customer provided photographs.The root cause is attributed to design.Corrective action was established via the depuy corrective and preventive action system.Additional corrective action is not indicated.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.
Additional 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 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.H6 patient code: no code available (3191) used to capture the insufficient information and surgery prolonged.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM DISTAL TAPERED 14X140
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8771704
• Report Number: 1818910-2019-97829
• Device Sequence Number: 2038898
• Product Code: KWA
• UDI-Device Identifier: 10603295076995
• UDI-Public: 10603295076995
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1976-14-140
• Device Catalogue Number: 197614140
• Device Lot Number: H64477
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 09/22/2020
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/21/2019; 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1