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).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• 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
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• 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: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 121887350
• Device Lot Number: 2908892
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR