MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 27X190A; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1977-27-190
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was revised to address loosening of the stem at the bone to implant interface.It was also stated that the stem spun and subsided because it was loose.The patient has had multiple revisions so bone quality was a major issue.So the surgeon removed the stem and placed in the 31mm reclaim.He also replaced with a new poly and head as well.Doi: (b)(6) 2018.Dor: (b)(6) 2020.Affected side: left hip.
Additional Manufacturer Narrative
Product complaint #: (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.

• Brand Name: RECLAIM DISTAL TAPERED 27X190A
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10755717
• Report Number: 1818910-2020-23555
• Device Sequence Number: 3333969
• Product Code: KWA
• UDI-Device Identifier: 10603295077459
• UDI-Public: 10603295077459
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1977-27-190
• Device Catalogue Number: 197727190
• Device Lot Number: 162561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RECLAIM DISTAL TAPERED 27X190A; RECLAIM PRX BDY CONE 24X95; RECLAIM DISTAL TAPERED 27X190A; RECLAIM PRX BDY CONE 24X95
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR