MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX60OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121887460

Device Problem Metal Shedding Debris (1804)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Skin Irritation (2076); Tissue Damage (2104); Joint Swelling (2356); Osteolysis (2377)

Event Date 08/01/2015

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

Clinical der states ae received for adverse reaction to metal debris.Event meets the definition of serious and is considered moderate.Event is definitely related to device and definitely not related to procedure.Currently awaiting revision.Update sep 12, 2017: additional information received.Patient has been revised due to metallosis.Revision of depuy head and liner occurred on (b)(6) 2017.Alert date for this info is 9-12-2017.Updated on sep 13, 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

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

Event Description

Update (b)(4) 2017.Medical records reviewed.Revision notes (b)(4) 2017 indicate the patient received a revision of left total hip arthroplasty acetabular component and femoral head, debridement pseudotumor and synovectomy, bone grafting to osteolytic defect posterior femoral metaphysis and trochanteric bed.The patient received this due to failed left total hip arthroplasty secondary to adverse reaction to metal debris as well as osteolysis proximal femur and trochanter.Indication for the procedure reveal the patient began to experience mild pain around the hip as well as swelling in his lower extremity.Mri and x-ray pre-revision revealed signs of fluid collection, osteolysis and resorption.Surgical findings include a pseudotumor that was excised.Plaque trunnionosis was noted on the taper of the head and trunnion on the stem.Osteolytic lesions were noted on the femur and trochanteric bed.Procedure was completed without indication of complication by the surgeon.Updated (b)(4) 2017.

Manufacturer Narrative

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

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 will be filed as appropriate.

Event Description

Complaint description: clinical der states ae received for adverse reaction to metal debris.Event meets the definition of serious and is considered moderate.Event is definitely related to device and definitely not related to procedure.Currently awaiting revision.Update sep 12, 2017: additional information received.Patient has been revised due to metallosis.Revision of depuy head and liner occurred on (b)(6) 2017.Alert date for this info is on (b)(6) 2017.Updated on sep 13, 2017 doi: on (b)(6) 2008; ae: on (b)(6) 2015 dor on (b)(6)2017 (left hip).Update sep 28, 2017.Medical records reviewed.Revision notes on (b)(6) 2017 indicate the patient received a revision of left total hip arthroplasty acetabular component and femoral head, debridement pseudotumor and synovectomy, bone grafting to osteolytic defect posterior femoral metaphysis and trochanteric bed.The patient received this due to failed left total hip arthroplasty secondary to adverse reaction to metal debris as well as osteolysis proximal femur and trochanter.Indication for the procedure reveal the patient began to experience mild pain around the hip as well as swelling in his lower extremity.Mri and x-ray pre-revision revealed signs of fluid collection, osteolysis and resorption.Surgical findings include a pseudotumor that was excised.Plaque trunnionosis was noted on the taper of the head and trunnion on the stem.Osteolytic lesions were noted on the femur and trochanteric bed.Procedure was completed without indication of complication by the surgeon.Updated 10-24-2017.

• Brand Name: PINNACLE MTL INS NEUT40IDX60OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6903319
• MDR Text Key: 87721439
• Report Number: 1818910-2017-25622
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887460
• Device Lot Number: 2723644
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 168