MAUDE Adverse Event Report: 1818910 DEPUY ORTHOPAEDICS, INC. PIN LNR CONS NEUT +4 36IDX56OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121836656

Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); No Information (3190); No Code Available (3191)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address a dislocation.It was noted intraoperatively that the locking ring had broken.

Manufacturer Narrative

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

Event Description

Update 4/29/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain, crunching, clicking and elevated metal ions that were addressed at first revision.Revision surgical report noted minor metallosis, broken locking ring and multiple small polyethylene fragments.Harms updated the complaint was updated on: may 19, 2016.

Manufacturer Narrative

Patient was revised to address a dislocation.It was noted intraoperatively that the locking ring had broken.Update 4/29/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain, crunching, clicking and elevated metal ions that were addressed at first revision.Revision surgical report noted minor metallosis, broken locking ring and multiple small polyethylene fragments.Harms updated no devices were returned to examine.One other report found against the 472293 lot code.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.No other reports found against the femoral head.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.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: PIN LNR CONS NEUT +4 36IDX56OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5571130
• MDR Text Key: 42444882
• Report Number: 1818910-2016-17228
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2016

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: 12/31/2018
• Device Catalogue Number: 121836656
• Device Lot Number: 472293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/19/2016; 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• 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
• Patient Age: 65 YR
• Patient Weight: 71