MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 PINNACLE SECTOR II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722056

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646)

Event Date 06/06/2018

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

(b)(6).Clinical adverse event received for acetabular component loosening, failure to ingrow.Event is serious.Event is related to both device and procedure.Doi: (b)(6) 2016, doe: (b)(6) 2018, dor: (b)(6) 2018, (left hip).

Event Description

(b)(6)-2018: medical records received.After review of the medical records for mdr reportability, revision operative note indicated pain, metallosis, possible infection, and cup loosening.The stem was noted to be well fixed.Progress note from (b)(6)-2018 confirmed infection-patient will have a picc placed for treatment.The head and liner are being added to the complaint.Medical history provided.Pc will be updated with the information provided.

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

• Brand Name: PINNACLE SECTOR II CUP 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7658373
• MDR Text Key: 113014246
• Report Number: 1818910-2018-63695
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009849
• UDI-Public: 10603295009849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121722056
• Device Lot Number: C32989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 11/27/2018
• Supplement Dates FDA Received: 07/25/2018; 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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 Weight: 98