MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK DEPUY CONSTRAINED LINER; HIP ACETABULAR INSERT/LINER

Catalog Number UNK-HIP

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923)

Patient Problems Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Injury (2348); Cancer (3262)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.See report for any product information received.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

(b)(6) 2015 medical records received.The medical records and claim were reviewed for mdr reportability.The claim reported the patient with severe pain, inflammation, tissue and bone loss, metallosis, increased metal ions, abductor necrosis, dislocation and revision surgeries on (b)(6) 2014 and (b)(6) 2015.The medical records reported dislocation, disassociated constrained liner, the greater trochanter void of muscle tissue, virtually no attachment of hip adductor muscles, necrotic tissue, and the bone around the acetabular cup extremely necrotic with poor quality and that kept it from being revised.There were no lab results for the alleged metal ions and no report of bone loss.The complaint was updated on: jan 8, 2016.

Manufacturer Narrative

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 codes were not provided.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).Depuy considers the investigation closed at this time.Should the 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

Pfs and medical records received.In addition to what was previously alleged, pfs alleges squishing noise, throbbing pain and difficulty in going up and down the stairs.After review of the medical records for the mdr reportability, patient was revised to address dislocation, abductor necrosis, bone necrosis and metallosis.Operative findings reported of discolored looking tissue at the base of the head which appeared to be necrotic.Clinical (b)(6) reported that liner was disassociated and hip dislocated when he was bending down.

Event Description

Update oct 5, 2017: litigation received.Litigation also alleges instability.Complaint updated on oct 23, 2017.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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 codes were not provided.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).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK DEPUY CONSTRAINED LINER
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 5360906
• MDR Text Key: 35691258
• Report Number: 1818910-2016-10557
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Weight: 68