MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM DISTAL TAPERED 16X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197616140
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
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
Stem fracture.
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 was reviewed and confirmed the stem had fractured.The device was reviewed by applied research and bioengineering and it was concluded that it is unlikely that a potential product issue was present.Root cause was deemed as undetermined.No corrective action is required.Post market surveillance per sep 419.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

• Brand Name: RECLAIM DISTAL TAPERED 16X140
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8159743
• Report Number: 1818910-2018-78024
• Device Sequence Number: 2203617
• Product Code: KWA
• UDI-Device Identifier: 10603295077039
• UDI-Public: 10603295077039
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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 Catalogue Number: 197616140
• Device Lot Number: H41110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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