MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER INSERT 36ID X 56OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121881756

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 07/20/2012

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

Event Description

On (b)(6) 2017: email notification received.Patient was revised for unknown reason.Components revised were head and liner.It was also mentioned that a formal litigation letter was sent.Update nov 21, 2017: medical records received.It was reported that the patient was revised to address dislocation, rotational and compression pain and click sound during walking due to pinnacle hip implant.Updated part and lot information.This complaint was updated on nov 21, 2017.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DELTA CER INSERT 36ID X 56OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7112966
• MDR Text Key: 94693955
• Report Number: 1818910-2017-29698
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121881756
• Device Lot Number: 3216149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 105