MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC* CEMENTED FEM STEM, SZ 3M; PFC HIP STEM AND LINER IMPLANTS : HIP FEMORAL STEM

Catalog Number 856613

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2006

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

Clinical adverse event received for deep infection.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2001, date of event (onset): (b)(6) 2006, (left hip).Treatment: hip was eventually explanted & revised in (b)(6) 2011, in another state/another hospital.

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.

• Type of Device: PFC HIP STEM AND LINER IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11333208
• MDR Text Key: 232011770
• Report Number: 1818910-2021-03072
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 856613
• Device Lot Number: 950481
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: P.F.C.* 32MM HEAD +0MM; PFC* CEMENTED FEM STEM, SZ 3M; PINN MAR +4 NEUT 32IDX56OD; PINNACLE SECTOR ACET CUP 56MM; UNKNOWN BONE CEMENT; P.F.C.* 32MM HEAD +0MM; PFC* CEMENTED FEM STEM, SZ 3M; PINN MAR +4 NEUT 32IDX56OD; PINNACLE SECTOR ACET CUP 56MM; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 107