MAUDE Adverse Event Report: DEPUY INTL., LTD. ¿ REG. # 8010379 ENDURON NEUT 50OD X 28ID; HIP ACETABULAR INSERT/LINER

Catalog Number 124110025

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Discomfort (2330)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the 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.(b)(4).

Event Description

Patient was revised to address extensive poly wear that was resulting in dislocation of the joint.There was probably some discomfort experienced by the patient.The continuous hip joint dislocation resulted in the surgeon opting for a revision of the liner.

Manufacturer Narrative

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

Manufacturer Narrative

Conclusion and justification status: the complaint states post op: removal of failed liner.Replaced with another poly liner and metal head.Above mentioned failed liner was removed.Replaced with a new liner and metal head.A review complaint databases did not identify any anomalies.The products were reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; 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: ENDURON NEUT 50OD X 28ID
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5636466
• MDR Text Key: 44553844
• Report Number: 1818910-2016-18712
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK944538
• 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,Followup
• Report Date: 04/14/2016

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: 10/11/2007
• Device Catalogue Number: 124110025
• Device Lot Number: 1052401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/08/2016; 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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