MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 60; HIP ACETABULAR CUP

Catalog Number 999800760

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The patient stated that the patient recently had blood tests and mri on inspection of my dupuy 2008 asr hip install with cobalt at 8.6 and chromium at 1.6.My doc says these should be under 1.0 and by all accounts my metals in blood are at toxic levels.The patient have surgery reports confirming the hip type and model by depuy.The patient also have metallosis, dead or contaminated tissue and possible a pseudo tumor shown in mri.The patient's mass general hip revision specialist doc says that the patient needs a revision asap as it is leaching into the patient's tissue and blood.Rather than get attorneys involved what is the guidance and assistance by j&j moving forward seeing the urgency to get this out of the patient's body? the patient prefer to get assistance as opposed to a long drawn out battle in the legal world.The patient takes no meds and in good health otherwise.

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.E3 (initial reporter occupation: lawyer).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: on (b)(6) 2008, the patient underwent depuy asr xl acetabular system on the left hip.On (b)(6) 2023, the patient noticed progressive problems with the left hip.On (b)(6) 2023, the patient was treated and was ordered an mri and blood testing for metal levels.Lab results revealed that chromium levels were abnormally high.Mri revealed osteolysis within the greater trochanter of the left hip with moderate joint effusion extending into the greater trochanteric bursa with internal debris.The patient had functionally disabling pain status post left metal-on-metal tha with elevated metal levels and abnormal mri consistent with adverse local tissue reactions.A revision tha was recommended and planned.On (b)(6) 2024, the patient underwent left total hip arthroplasty.Following the surgery, the patient's cobalt and chromium levels remained abnormally high.During the revision surgery, a large amount of necrotic soft tissue surrounding the metal-on-metal hip joint required debriding, and upon entering the joint there was extensive evidence of metal debris, metallic stained fluid, and corrosion.An approximately 50% loss of abductor muscles was noted.The metal femoral head device was removed, the corroded trunnion was cleaned, a ceramic femoral head device was implanted onto the trunnion, and a polyethylene liner was inserted into the existing asr acetabular cup.The asr cup was left in place to reduce the morbidity involved with cup extraction.As a result of the asr failure, revision surgery, extensive metal debris, corrosion, tissue necrosis, abductor muscle loss, osteolysis, and cobalt and chromium poisoning, the patient has suffered severe and permanent physical and mental injuries.Doi: (b)(6) 2008.Dor: feb 13, 2024.Left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: added: a2 (age, dob), a4, b5, b6, b7, d4 (lot, uid, expiration date), d6a, d6b, e1 (hospital), g4 (pma), h4, h6 (clinical, impact, and medical device problem code) corrected: d1, d2a, d4 (catalog).

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

• Brand Name: ASR ACETABULAR CUPS 60
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18142847
• MDR Text Key: 328195694
• Report Number: 1818910-2023-23325
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2011
• Device Catalogue Number: 999800760
• Device Lot Number: 2188350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 05/15/2024; 05/22/2024
• Supplement Dates FDA Received: 12/07/2023; 05/16/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +8; ASR UNI FEMORAL IMPL SIZE 53; SUMMIT DUOFIX TAP SZ6 HI OFF; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 122 KG