MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR LIP LNR 28IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 121928250

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

Patient Problems Pain (1994); Discomfort (2330); Joint Swelling (2356); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/18/2017

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

Litigation record received.Litigation alleges pain, swelling and inability to walk, sit or lay down.There is no report of revision at this time.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(6).

Event Description

Pfs and medical records received.In addition to what was previously alleged, pfs alleges limited activity.After review of medical records for reportability, clinic visits reported of popping on hip when leaning, probable subluxation, discomfort, pain, unable to lie at right side and pain reported when trochanteric bursa was palpated.Radiographs revealed that the tip of the stem have caused some remodelling of the shaft of the femur.

Manufacturer Narrative

If information is obtained that no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Was not available for the initial 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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).

• Brand Name: PINN MAR LIP LNR 28IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN ; UK
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; in; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7038426
• MDR Text Key: 92283369
• Report Number: 1818910-2017-29125
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup

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: 03/31/2010
• Device Catalogue Number: 121928250
• Device Lot Number: ZL7C61000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 12/01/2017; 01/17/2018; 01/17/2018; 05/30/2018; 11/13/2018
• Supplement Dates FDA Received: 12/07/2017; 01/30/2018; 01/31/2018; 05/31/2018; 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2005
• 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 Age: 85 YR
• Patient Weight: 84