MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-052

Device Problem Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 12/06/2018

Event Type  Injury  

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

It was reported that post operative insert breakage.The patient accepted tha on (b)(6) 2018.No anomaly was observed during procedure.After 5 months patient felt pain and returned back hospital.It was noted that insert broke and implant loosened on (b)(6) 2018.The revision surgery will be operated.Now patient condition is stable.

Manufacturer Narrative

(b)(4).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.

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.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8217004
• MDR Text Key: 132061039
• Report Number: 1818910-2019-79857
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1217-22-052
• Device Catalogue Number: 121722052
• Device Lot Number: 8637691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 60