MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC. US PINNACLE SECTOR II CUP 62MM; HIP METAL ACETABULAR CUPS

Catalog Number 121722062

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Weakness (2145); Ambulation Difficulties (2544)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

(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

Alleges pain, fatigue, muscle weakness, difficulty walking and standing.After review of medical records for mdr reportability it was reported that the patient was revised to address recurrent dislocation.Revision note states, there was evidence of previous posterior dislocation with a large amount of hemarthrosis in and around the joint.Assessment of the acetabulum revealed that indeed the positioning of the cup was slightly under anteverted, especially given his history of back fusion.Doi: cup (b)(6) 2010.Doi: liner and head (b)(6) 2017 : dor: (b)(6) 2017 (left hip re-revision).

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.

Manufacturer Narrative

Udi: (b)(4).

• Brand Name: PINNACLE SECTOR II CUP 62MM
• Type of Device: HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC. US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st. anthony's road; leeds IN ; UK
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7269486
• MDR Text Key: 100000889
• Report Number: 1818910-2018-53388
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009870
• UDI-Public: 10603295009870
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2018

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
• Device Operator: No Information
• Device Expiration Date: 09/24/2017
• Device Catalogue Number: 121722062
• Device Lot Number: B4DF51000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/10/2018
• Supplement Dates FDA Received: 08/31/2018; 10/11/2018
• Date Device Manufactured: 09/24/2007
• 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 Age: 73 YR
• Patient Weight: 109