MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887350

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Loss of Range of Motion (2032); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Occupation: a non-healthcare professional. (b)(4).

Event Description

The patient was revised to address chronic instability, osteolysis, recurrent dislocation and chronic infection. Operative findings include a copious amount of hematoma and metal stained soft tissue with the appearance of pseudotumor in the pericapsular tissue. There was severe proximal femoral osteolysis with erosion of the proximal femur at the level of the lesser trochanter. Upon removal of the femoral stem, a fracture occurred around the trochanter region. A cerclage cable was placed. The metal-on-metal liner was found to be cold-welded to the cup and could not be disengaged. There was also severe osteolysis on the acetabulum. Notes from visits to the physician indicate patient was also having limited range of motion and gait instability. Non-depuy antibiotic spacers were placed. Doi: (b)(6) 2009. Dor: (b)(6) 2017, (right hip).

• Brand Name: PINNACLE MTL INS NEUT36IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8793248
• MDR Text Key: 151121224
• Report Number: 1818910-2019-98431
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 121887350
• Device Lot Number: 2908892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/16/2019 Patient Sequence Number: 1