MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CER HEAD 12/14 28MM +5; HIP FEMORAL HEAD

Catalog Number 136528320

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

The surgeon mistakenly inserted the delta head for the stem manufactured by a competitor and completed the surgery without any delay.Revision will be conducted in order to remove the head and insert the metal head manufactured by the same competitor.

Manufacturer Narrative

Conclusion and justification status: the complaint states during tha on (b)(6) 2016, the surgeon mistakenly inserted the delta head for the stem manufactured by a competitor and completed the surgery without any delay.Revision will be conducted in order to remove the head and insert the metal head manufactured by the same competitor.A complaint database search did not identify any anomalies.The complaint shall be closed as user error; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).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: DELTA CER HEAD 12/14 28MM +5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, muenster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5847137
• MDR Text Key: 51171813
• Report Number: 1818910-2016-24514
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• 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: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 136528320
• Device Lot Number: 8198010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention