MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE; METAL ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Event Description

Pinnacle litigation records received.Records alleges pain, injury, tissue and bone destruction, metal wear, emotional trauma and distress, toxic cobalt and chromium metal ions poisoning.Doi: (b)(6) 2009.Dor: (b)(6) 2020; unknown hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 clinical code) appropriate term / code not available (e2402) is used to capture blood heavy metal increased.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records patient was revised to address metal ion disease.There was extensive staining of the soft tissue, a quite soft tissue loss of the gluteal muscles, psoas muscle.Upon removing the acetabulum, there was extensive cavity bone loss superiorly and along the pubis infer medially to the cup.Doi: (b)(6) 2009, dor: (b)(6) 2020 , right hip.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: patient x-ray images have been provided for review.No device associated with this report was received for examination.Patient x-ray images have been provided for review.Two of which are dated on (b)(6) 2009, the date of the primary surgery.Two are post revision.Nothing indicative of a product problem is identified.A root cause for the problems reported cannot be determined from the provided imagery.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: a worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required part/lot number was not provided.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d10 concomitant.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.Unspecified tissue injury (e2015) is being utilized to capture bone injury & soft tissue injury.

Manufacturer Narrative

Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (clinical code).

Event Description

Medical records were received and stated the following: revision notes stated that pinnacle cup, trilock stem, metal liner, and metal head were removed during revision.(b)(6) 2009 the patient had a right total hip arthroplasty to address severe degenerative joint disease right hip with leg length discrepancy.Components implanted were depuy products.On (b)(6) 2020, the patient had a right revision total hip arthroplasty to address metal ion disease, with metallosis and elevated serum metal ion levels.During the procedure the surgeon observed quite a bit of soft tissue loss of the gluteal muscles, psoas muscle.There was extensive cavitary bone loss.The acetabular cup/liner were revised.On (b)(6) 2020 medical records note the patient dislocated hip while still under anesthesia from the previous revision the patient was re-prepped and redraped and the hip was reentered.The problem was noted to be mechanical impingement of the femoral neck against the elevated lip polyethylene liner.The articulation and we removed the elevated liner and placed zimmer liner with a biomet biolox delta ceramic head.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required part/lot number was not provided.

Manufacturer Narrative

Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and b6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After a review of the medical records, on (b)(6) 2020, laboratories result on synovasure neutrophil elastase indicated positive.However, in previous operative notes, there has been no indication of hip infection.

• Brand Name: UNK HIP ACETABULAR LINER METAL PINNACLE
• Type of Device: METAL ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11653074
• MDR Text Key: 245079468
• Report Number: 1818910-2021-07704
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR HOLE ELIMINATOR; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM TRI-LOCK; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male