MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY ACETABULAR LINER; HIP ACETABULAR INSERT/LINER

Catalog Number UNK-HIP

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Anemia (1706); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Septic Shock (2068); Thrombosis (2100); Ambulation Difficulties (2544); Blood Loss (2597)

Event Date 02/28/2017

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.

Event Description

On 21 aug 2017: litigation received.Litigation alleges friction and wear between the cobalt-chromium metal head and metal liner, pain, discomfort, inability to do adl, and elevated cobalt and chromium levels.It also alleges that revision findings reported "some serous fluid in the joint itself that did not appear purulent but was certainly inflammatory in nature.The tissue that was black and around the hip joint was meticulously dissected." there are no medical records and laboratory values provided.

Manufacturer Narrative

Additional narrative: no device associated with this report was received for examination.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

No device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what were previously alleged, pfs alleges acute deep vein thrombosis associated with picc and requiring full-dose anticoagulation; acute blood loss anemia requiring 5 units blood transfusion; transfusion associated volume overload; large soft tissue hematoma requiring evacuation; wound infection secondary to septic shock; acute renal failure; left hip wound irrigation and debridement; removal of femoral head with exchange; follow up wound care for pain and wound drainage; and lifetime antibiotic treatment.

• Brand Name: UNKNOWN DEPUY ACETABULAR LINER
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6877089
• MDR Text Key: 86658955
• Report Number: 1818910-2017-24942
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2017

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 Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 10/17/2017; 12/12/2017; 01/12/2018
• Supplement Dates FDA Received: 10/18/2017; 12/28/2017; 01/17/2018
• 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: 66 YR
• Patient Weight: 91