MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121703052

Device Problems Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Rash (2033); Swelling (2091); Tissue Damage (2104); Injury (2348); Fibrosis (3167); Not Applicable (3189)

Event Date 05/03/2011

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

New etq record created in order to udpate etq (legacy system) complaint number (b)(4).Reason for original complaint.Maude event report states: i had a total hip replacement using the depuy pinnacle acetabular cup, pinnacle metal insert, depuy corail stem, metal on metal femoral head.Soon after the surgery, i developed a rash starting from the hip/groin area to the top of my foot and i had drainage from the surgery site for 10 days later after the surgery.Additionally, i continued to have severe groin pain and extreme difficulty walking after the surgery which never subsided, it only continued to get worse.Additionally, i developed heterotopic ossification after the surgery.I went back at least 9 times to see my orthopedic surgeon and he continued to say the pain would go away with time which it never did.In 2010 i was tested for metal allergies and it was determined i was highly allergic to nickel.In 2011, the x-rays showed a loosening of the femoral stem so i was scheduled to have revision hip replacement surgery.On (b)(6) 2011, i had revision hip replacement surgery and the following are the findings of the orthopedic surgeon: severe metalosis, heterotopic ossification, 2-3 inches of the femur bone was deteriorated due to the nickel allergy and the ball, socket and liner had to be replaced with nickel free prosthesis.Doi: (b)(6) 2010 - dor: (b)(6) 2011.Update: (b)(6) 2012 - litigation papers received (b)(6) 2012.There is no new additional information that would affect the investigation.Update: (b)(6) 2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update: ad (b)(6) 2018: pfs, ppf and medical records received.In addition to what were previously alleged.Pfs alleges injury, pain, rash, swelling, and metallosis.Ppf alleges metal wear and metallosis after the initial hip implant.Ppf also alleges loosening of stem after the revision.After review of medical records for mdr reportability, the patient was revised to address pain, and allergy with metal reaction due to nickel debris.Revision notes reported thickened joint capsule and a creamy yellow purulent material, reactive membrane and fribrinous debris, erosion about the margin of the acetabular shell, the metal liner was difficult to remove thus the whole acetabular component were explanted with minimal bone loss.Stem was elected to be retained.Metal ion levels were below 7 ppb.Doi: (b)(6) 2010; dor: (b)(6) 2011; right hip.This complaint was updated on: (b)(6) 2018.See (b)(4) for the second revision.

Manufacturer Narrative

(b)(4).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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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.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 300 ACET CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7494365
• MDR Text Key: 107593967
• Report Number: 1818910-2018-59108
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295008651
• UDI-Public: 10603295008651
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2019
• Device Catalogue Number: 121703052
• Device Lot Number: D77C71000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 98