MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINNACLE SECTOR II CUP 58MM; HIP ACETABULAR CUP

Model Number 1217-22-058

Device Problems Disassembly (1168); Fracture (1260); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Date 11/26/2014

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.

Event Description

Litigation received.Litigation alleges metal debris and increased metal ion levels.Update 15 aug 2017: pfs and medical records received.In addition to what was previously alleged, patient also alleges pain, multiple hip dislocations and extreme soreness.After review of medical records for mdr reportability it was reported that the patient was revised to address failed left total hip replacement.Revision notes reported polyethylene was dislodged from the acetabulum, small amount of metal debris was present, and minimal to no trunnion corrosion present.Updated the part and lot information.This complaint was updated on: aug 22, 2017.Update aug 15, 2017: medical records reviewed.In addition, revision notes also state that the head was articulating on the inner shell of the cup in the central portion.Adding cup for the reported disassociation.This complaint was updated on: sep 12, 2017.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Ppf and sticker sheets received.In addition to what were previously alleged, ppf alleges component fracture but was not specified which component fractured.However, medical records provided previously did not indicate any implant fracture found during the revision surgery.Doi (b)(6) 2013 - dor: (b)(6) 2014 - left hip.

Manufacturer Narrative

Product complaint # (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

Ppf record received alleges implant fracture but not known which implant fractured.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: h6 patient code: no code available (3191) was used to capture surgical intervention.

• Brand Name: PINNACLE SECTOR II CUP 58MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6865547
• MDR Text Key: 86152371
• Report Number: 1818910-2017-24627
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009856
• UDI-Public: 10603295009856
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/15/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 1217-22-058
• Device Catalogue Number: 121722058
• Device Lot Number: 350047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 01/08/2019; 01/08/2019; 07/06/2020
• Supplement Dates FDA Received: 01/10/2019; 01/25/2019; 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 114