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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Synovitis (2094); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Date 03/01/2023
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.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 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation asr complaint received ad (b)(6) 2023.Patient was revised was due to pain, discomfort, increased metal ion levels including cobalt and chromium, permanent injuries, emotional distress, disfigurement, disability and economic damages.Doi: (b)(6) 2008.Dor: (b)(6) 2023.Left hip.
 
Event Description
Medical records were received: patient was revised due to acute left pain, suspected fluid collection/ metallosis now abutting the sciatic nerve.Ion levels are quite high, moderate amount reactive synovitis/inflammatory tissue with metal staining consistent with adverse local tissue reaction ( altr ) or metallosis and that this is a known complication with metal on metal implants.Most likely, the stem was left in place.The cup was revised and used a polyethylene bearing.Doi: (b)(6) 2008.Dor: (b)(6) 2023.Affected side: left hip.
 
Manufacturer Narrative
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 device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative:.
 
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: a4, b5, b7, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, d10 concomitant.
 
Event Description
Medical records received.Patient experienced anxiety due to all the damage that the asr has caused and about any future damage that the high levels and metal in his bloodstream can cause.
 
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.Unspecified tissue injury (e2015) is being utilized to capture soft tissue injury & bone injury.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 received.The patient sustained injuries to his tendons, ligaments, tissues, and bones within his hip.The patient suffered from lower back pain and left leg pain.The patient has high cobalt and chromium levels.The surgeon found metallosis.Continue to suffer discomfort and soreness.The patient is anxious about all the damage.
 
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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 Key17482514
MDR Text Key320656865
Report Number1818910-2023-16299
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
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 08/08/2023
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 Date02/28/2013
Device Catalogue Number999800318
Device Lot Number2562254
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/25/2023
Initial Date FDA Received08/08/2023
Supplement Dates Manufacturer Received08/22/2023
10/26/2023
12/26/2023
Supplement Dates FDA Received08/22/2023
10/31/2023
01/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2008
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 56; ASR UNI FEMORAL IMPL SIZE 49; SUMMIT POR TAPER SZ8 STD OFF; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexMale
Patient Weight82 KG
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