MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX54OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121887354

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032)

Event Date 10/26/2017

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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2017: litigation records received.Litigation alleges pain, suffering, and debility.There is no revision reported at this time.No part and lot information provided.

Manufacturer Narrative

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

(b)(4).

Event Description

Update oct 26, 2017: pfs and medical records received.Pfs also alleges muscle spasms, limited range of motion and audible clicks.After review of medical records, there is no new information.Updated part and lot information.This complaint was updated on: nov 2, 2017.

Manufacturer Narrative

(b)(4).

Event Description

Update oct 26, 2017: pfs and medical records received.Pfs also alleges muscle spasms, limited range of motion and audible clicks.After review of medical records, there is no new information.Updated part and lot information.This complaint was updated on nov 2, 2017.

Manufacturer Narrative

(b)(4).

Event Description

Update oct 26, 2017: pfs and medical records received.Pfs also alleges muscle spasms, limited range of motion and audible clicks.After review of medical records, there is no new information.Updated part and lot information.This complaint was updated on: nov 2, 2017.

Manufacturer Narrative

(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.

Event Description

Complaint description: aug 17, 2017: litigation records received.Litigation alleges pain, suffering, and debility.There is no revision reported at this time.No part and lot information provided.Update oct 26, 2017: pfs and medical records received.Pfs also alleges muscle spasms, limited range of motion and audible clicks.After review of medical records, there is no new information.Updated part and lot information.This complaint was updated on: nov 2, 2017.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 6869379
• MDR Text Key: 86332967
• Report Number: 1818910-2017-24833
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/26/2017

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 Expiration Date: 02/01/2015
• Device Catalogue Number: 121887354
• Device Lot Number: 3079953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 10/09/2017; 10/26/2017; 10/26/2017; 10/26/2017; 08/15/2018
• Supplement Dates FDA Received: 10/13/2017; 11/03/2017; 11/03/2017; 11/06/2017; 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2010
• Is the Device Single Use?: No
• 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: 67 YR
• Patient Weight: 75