MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PINNACLE SECTOR II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722050

Device Problem Osseointegration Problem (3003)

Patient Problems Inflammation (1932); Swelling (2091); Discomfort (2330); Inadequate Osseointegration (2646)

Event Date 02/06/2012

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

Complaint description: new etq created in order to update etq (legacy system).Complaint number: (b)(4).Reason for original complaint- litigation papers allege: on or about (b)(6) 2003, patient was implanted with a depuy pinnacle mom hip implant on her left side.Patient continues to suffer with pain, swelling, inflammatory reactions, loosening of her implant, difficulty walking, fear of more dislocations as she has had about 43 dislocations already, grinding sensations, and allergic reactions to metallic debris with ongoing rashes, and scarring of the hip area.Due to her chronic pain, discomfort, and other symptoms, patient continues to require ongoing medical care.A revision surgery has been recommended by her physician and is currently being scheduled.Update: 12/17/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Complaint was updated on: 6/3/2014.Update ad 23 april 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and implant record.Ppf has no allegation reported.After review of medical records attached in the com, patient was revised to address pain and instability with multiple dislocation of left hip.It was stated that cup found to be loose.Cup was added to impacted product since it was also indicated that it was removed.Doi: (b)(6) 2003; dor: (b)(6) 2012; (left hip).

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 50MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 5743725905
• MDR Report Key: 7812419
• MDR Text Key: 118101612
• Report Number: 1818910-2018-67588
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009818
• UDI-Public: 10603295009818
• 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
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121722050
• Device Lot Number: W3THN1004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 77