MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEM FEM STEM 13X150MM BOW; HIP FEMORAL STEM

Catalog Number 198715213

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Abscess (1690); Calcium Deposits/Calcification (1758); Bone Fracture(s) (1870); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Weakness (2145); Anxiety (2328); Discomfort (2330); Ambulation Difficulties (2544); Fibrosis (3167); No Code Available (3191)

Event Date 08/23/2019

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.Occupation is a non-healthcare professional.

Event Description

Medical records received.After review of the medical records, the patient was revised to address infection resulting to pain, swelling, redness, weakness instability, loosening of the distal stem, subsidence of the femoral stem, heterotopic ossification to a the acetabular component.Operative note reported dense fibrinous tissue surrounding the implant proximally.This was sent for culture however no acute inflammation to suggest presence of infection.Fracture at the proximal most portion of the femoral stem.Doi: (b)(6) 2017; dor: (b)(6) 2019: right hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿ added: d4 (procode,lot,exp,udi), d11 and h4.Corrected: a1, d1 and d2.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿.Added: b5, b6, d11 and h6 (patient).No code available is used to capture device revision or replacement.

Event Description

After review of the medical records, in addition to the clinical visit reported on (b)(6) 2019 patient had redness, tenderness in the wound and develop anxiety.

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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: patient code: no code available (3191) was used to capture joint instability and osteomyelitis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records, visit notes reported that patient had difficulty in walking.

• Brand Name: LPS CEM FEM STEM 13X150MM BOW
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10275842
• MDR Text Key: 198900976
• Report Number: 1818910-2020-15893
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 198715213
• Device Lot Number: 661626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+12; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN LNR CON +4 NEUT 40IDX62OD; PINN MULTIHOLE W/GRIPTION 62MM; PINNACLE BONE SCREW 60 MM; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR