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

Model Number 1977-27-190

Device Problems Loss of Osseointegration (2408); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/12/2020

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

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.

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
• Type of Device: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10755717
• MDR Text Key: 213679099
• Report Number: 1818910-2020-23555
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295077459
• UDI-Public: 10603295077459
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1977-27-190
• Device Catalogue Number: 197727190
• Device Lot Number: 162561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RECLAIM DISTAL TAPERED 27X190A; RECLAIM PRX BDY CONE 24X95; RECLAIM DISTAL TAPERED 27X190A; RECLAIM PRX BDY CONE 24X95
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR