MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 28X85; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1975-28-085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Test Result (2695); No Code Available (3191)
Date of Event	05/13/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Complaint description: patient was revised to address infection.Update 12/8/2014- pfs and medical records received.A correct doi was provided.This complaint is now legal.There are no specific allegations for this revision.After review of the medical records for mdr reportability, the revision operative note indicated inflammation, subluxation, and no infection as previously stated.Only the liner was changed to a competitor constrained liner.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 1/6/2015.Update ad 30 jul 2019: (b)(4) has been re-opened under (b)(4) due to ppf and implant record.Ppf alleges fracture, dislocation with open reduction and elevated metal ions.Doi: (b)(6) 2013 - dor: (b)(6) 2014, (left hip).
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: RECLAIM PRX BDY CONE 28X85
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8910426
• Report Number: 1818910-2019-101663
• Device Sequence Number: 1400648
• Product Code: KWA
• UDI-Device Identifier: 10603295076964
• UDI-Public: 10603295076964
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2014

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?: No
• Operator of Device: No Information
• Device Expiration Date: 04/30/2022
• Device Model Number: 1975-28-085
• Device Catalogue Number: 197528085
• Device Lot Number: 236341
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 88