MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Myocardial Infarction (1969); Renal Failure (2041); Thrombosis (2100); Tissue Damage (2104); Joint Dislocation (2374); Respiratory Tract Infection (2420); No Code Available (3191)

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. Pertains to 18 patients.

Event Description

(b)(6) 2019: ¿cemented or cementless tha in patients over 80 years with fracture neck of femur: a prospective comparative trial¿ was reviewed for mdr reportability. The study followed 62 patients that were divided into two groups. Group 2: duraloc cup augmented with screws, corail or summit stem, 28mm femoral head, and polyethylene liner. Group 2: two patients experienced a dislocation. Twelve patients experienced abductor dysfunction. Four patients experienced non-fatal systemic complications (dvt, renal failure, mi, and pulmonary infection).

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8337450
• MDR Text Key: 136107277
• Report Number: 1818910-2019-84477
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/13/2019 Patient Sequence Number: 1