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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800756
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Date 12/09/2022
Event Type  Injury  
Event Description
Asr litigation record received.Litigation alleges asr alleges severe pain, discomfort, increased metal levels in blood including cobalt and chromium, permanent injuries, emotional distress, disfigurement and economic damages.Doi: (b)(6) 2008.Dor: (b)(6) 2022 right hip.
 
Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.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.
 
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.
 
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.
 
Event Description
Additional information received indicated that the patient was revised due to metallosis.Mri revealed pseudotumor.
 
Event Description
Medical records were received: asr plaintiff fact sheets received.In addition to what previously alleges in pfs, it alleges injuries to tendons, ligaments, tissues and bones, fluid build up, metallosis, muscle stiffness and walking difficulty and anxiety.Doi: (b)(6) 2008; dor: (b)(6) 2022.Right 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.Update:01-jan-2024.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.
 
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Brand Name
ASR ACETABULAR CUPS 56
Type of Device
ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key16952071
MDR Text Key315444541
Report Number1818910-2023-10421
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 05/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/14/2012
Device Catalogue Number999800756
Device Lot Number2495528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2007
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
ADAPTER SLEEVES 12/14 +5.; ADAPTER SLEEVES 12/14 +5.; ASR ACETABULAR CUPS 56.; ASR UNI FEMORAL IMPL SIZE 49.; ASR UNI FEMORAL IMPL SIZE 49.; SUMMIT POR TAPER SZ4 STD OFF.; SUMMIT POR TAPER SZ4 STD OFF.; UNK HIP FEMORAL HEAD METAL ASR.; UNK HIP FEMORAL SLEEVE ASR.; UNKNOWN HIP FEMORAL STEM.
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexMale
Patient Weight88 KG
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