MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 50MM; HIP ACETABULAR CUP

Catalog Number 121722050

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

Udi: (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

Pfs and medical records received for (b)(4).While reviewing the medical records for mdr reportability, the records indicated the patient was revised (covered in (b)(4)) and was then revised a second time on (b)(6) 2016.The revision operative note indicated a loose cup, pain, and the polyethylene debris was loose.Its unknown what is meant by the debris was loose, but it will be coded for poly wear at this time.Its believed the cup reported for loosening was from the first doi of (b)(6) 2010.The head and liner were placed during the first revision which the date and part/lot information is unknown at this time.

Manufacturer Narrative

Pfs and medical records received for (b)(4).While reviewing the medical records for mdr reportability, the records indicated the patient was revised (covered in (b)(4)) and was then revised a second time on (b)(6) 2016.The revision operative note indicated a loose cup, pain, and the polyethylene debris was loose.Its unknown what is meant by the debris was loose, but it will be coded for poly wear at this time.Its believed the cup reported for loosening was from the first doi of (b)(6) 2010.The head and liner were placed during the first revision which the date and part/lot information is unknown at this time.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.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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.Depuy 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.

Manufacturer Narrative

(b)(4).

Event Description

Update 02/23/2017 ¿pfs and medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, part/lot numbers provided.The complaint was updated on: 03/16/2017.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy 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: PINNACLE SECTOR II CUP 50MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 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: 6195293
• MDR Text Key: 62997946
• Report Number: 1818910-2016-33833
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2017

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 Catalogue Number: 121722050
• Device Lot Number: EP6J41000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2017; 03/16/2017; 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2010
• 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: 57 YR
• Patient Weight: 118