MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM DISTAL TAPERED 17X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197617140
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	01/05/2019
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.(b)(4).
Event or Problem Description
It was reported that the patient came in with a right peri-prosthetic hip fracture that was also infected.Removed all reclaim and pinnacle implants and wired up femur and implanted a prostalac stem and cup.The stem was loose at the bone to implanted interface because of the fracture.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: RECLAIM DISTAL TAPERED 17X140
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8277185
• Report Number: 1818910-2019-82248
• Device Sequence Number: 14042643
• Product Code: KWA
• UDI-Device Identifier: 10603295077053
• UDI-Public: 10603295077053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2019

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: Health Professional
• Device Catalogue Number: 197617140
• Device Lot Number: HY9847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/05/2019
• 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: 69 YR