MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ANGLED ACET INSERTR; HIP INSTRUMENT/TRIAL

Catalog Number 920010029

Device Problems Break (1069); Detachment Of Device Component (1104); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Defect plastic part to fix the cup to impactor.-the locking catch has a piece broken off, the piece has not been returned.

Manufacturer Narrative

Conclusion and justification status: the complaint states defect plastic part to fix the cup to impactor.The investigation confirmed that the locking catch had fractured as reported.Previously a corrective action was identified for this failure mode whereby a design change was implemented and routed on (b)(4) in 2007 in order to strengthen the locking catch.The design verification was completed and routed on (b)(4) and concluded that there are no outstanding actions identified.The complaint shall be closed with a justified conclusion it will be entered into the complaint database and monitored through trend analysis.Depuy still considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ANGLED ACET INSERTR
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5390205
• MDR Text Key: 36986639
• Report Number: 1818910-2016-11777
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 920010029
• Device Lot Number: PC30412001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1