MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121712048
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/27/2018
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.Concomitant med products: delta cer head 12/14 32mm +1 hip femoral head; pinn mar +4 10d 32idx48od hip acetabular liner; pinn sector ha acet cup 48mm hip acetabular cup; unknown hip femoral stem.
Event or Problem Description
Revision; dr (b)(6), (b)(6) surgical centre (b)(6) 2018.Primary implantation date: (b)(6) 2015.Patient presented to dr (b)(6), she had developed squeaking in her hip last wednesday.Surgery booked and xrays revealed eccentric positioning of liner and dislodgement, for liner and head exchange with constrained liner as a backup.During surgery metallosis observed and fragments of poly and coating of ceramic head noted.Replacement liner and head put into patient.Damaged femoral head impactor tip and liner trial in the process.Dr (b)(6) has requested an investigation as this has happened before and is concerned it is a poly fault.Female patient id: (b)(6), initials (b)(6), dob: (b)(6), aged (b)(6).
Additional Manufacturer Narrative
(b)(4).Investigation summary :examination of the returned device(s) confirms the reported event.Product problem has not been identified.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 will be filed as appropriate.

• Brand Name: PINN SECTOR HA ACET CUP 48MM
• 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: 7893586
• Report Number: 1818910-2018-69882
• Device Sequence Number: 11121217
• Product Code: LPH
• UDI-Device Identifier: 10603295009146
• UDI-Public: 10603295009146
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 121712048
• Device Lot Number: 614460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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 Age: 62 YR