MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM LOCKING BOLT 85MM; RECLAIM IMPLANT : HIP FEMORAL AUGMENT

Model Number 1975-00-085

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Patient received stage one of a two stage revision to treat infection.Doi: (b)(6) 2016.Dor: (b)(6) 2022.Left hip.

• Brand Name: RECLAIM LOCKING BOLT 85MM
• Type of Device: RECLAIM IMPLANT : HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13666718
• MDR Text Key: 286567518
• Report Number: 1818910-2022-04098
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295076841
• UDI-Public: 10603295076841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 1975-00-085
• Device Catalogue Number: 197500085
• Device Lot Number: 236170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OSTEOLOCK ACETABULAR SHELL 62MM; RECLAIM DISTAL TAPERED 17X190; RECLAIM PRX BDY CONE 20X85; SYSTEM 12 DURATION LINER 10 DEGREES 32MM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG