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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +8; FEMORAL SLEEVE
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DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +8; FEMORAL SLEEVE Back to Search Results
Catalog Number 999800318
Device Problems Degraded (1153); 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).D4: the device catalog number is unknown; therefore, udi is unavailable.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 (b)(6) 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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.
 
Event Description
Medical records were received: on (b)(6) 2008, the patient underwent depuy asr xl acetabular system on the left hip.On june 26, 2023, the patient noticed progressive problems with the left hip.On october 4, 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: (b)(6) 2024 left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Product description:- adapter sleeves 12/14 +8.Product code:- 999800318.Lot no:- 2587240.Quantity of manufactured:- 25.Date of manufacturing:- mar-2008.Expiry date:- mar-2013.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 : product description:- adapter sleeves 12/14 +8.Product code:- 999800318.Lot no:- 2587240.Quantity of manufactured:- (b)(4).Date of manufacturing:- mar-2008.Expiry date:- mar-2013.Device history review : a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10.
 
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Brand Name
ADAPTER SLEEVES 12/14 +8
Type of Device
FEMORAL SLEEVE
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 Key18142812
MDR Text Key328225029
Report Number1818910-2023-23324
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
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 Date03/21/2013
Device Catalogue Number999800318
Device Lot Number2587240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/04/2023
Initial Date FDA Received11/15/2023
Supplement Dates Manufacturer Received11/29/2023
05/06/2024
05/22/2024
Supplement Dates FDA Received12/07/2023
05/16/2024
05/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; SUMMIT DUOFIX TAP SZ6 HI OFF; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight122 KG
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