MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121712050
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Separation Problem (4043)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional 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.(b)(4).
Event or Problem Description
Patient underwent spinal surgery after her hip was replaced and then reported ongoing groin pain she dislocated requiring revision surgery.During revision surgery black substance was noted around the corail stem trunnion and the ceramic head was black.Liner disassociated from the cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN SECTOR HA ACET CUP 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8468889
• Report Number: 1818910-2019-89110
• Device Sequence Number: 1575806
• Product Code: LPH
• UDI-Device Identifier: 10603295009153
• UDI-Public: 10603295009153
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 121712050
• Device Lot Number: C52278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 65