MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM DISTAL TAPERED 18X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number 1976-18-140

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

Patient Problems Adhesion(s) (1695); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Clinical symptoms code: appropriate term/code not available (e2402) used to capture infections.Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Unf and medical records received.After review of the medical records the patient was revised due to unstable acetabular cup and draining sinus from left hip resulting to painful and infected left hip arthroplasty.Operative note reported there was extensive evidence of a sinus tract, infection present and lab result confirmed increase wbc.Cup was grossly loose and scar tissue were removed.Doi: (b)(6) 2015: dor: (b)(6) 2019; left hip (2nd revision).

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 18X140
• Type of Device: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10992137
• MDR Text Key: 220935126
• Report Number: 1818910-2020-26805
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295077077
• UDI-Public: 10603295077077
• Combination Product (y/n): N
• PMA/PMN Number: K102080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1976-18-140
• Device Catalogue Number: 197618140
• Device Lot Number: 574915
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RECLAIM DISTAL TAPERED 18X140; RECLAIM PRX BDY CONE 20X75; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; RECLAIM DISTAL TAPERED 18X140; RECLAIM PRX BDY CONE 20X75; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR