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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890251
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr litigation record received.Patient alleges that the acetabular cup eventually detached, disconnected, created metallic debris, and/or loosened from patient's acetabulum, grinding, and clicking for several months, caused patient's severe pain, and inhibited ability to walk.Doi: (b)(6) 2008 - dor: (b)(6) 2020 (left hip).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: added: a2 (age, birth date), b5, b6, b7, d2b, d4 (procode,lot,exp), h4 and h6 (patient).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the medical device site erosion.Corrected: a1, d1, d2, d10 and g1.
 
Event Description
After review of medical record, patient was revised to address metalosis.Patient had elevated metal ion.Revision notes stated that there is significant inflammation of the capsule.There was some erosion of the bone on the inferior aspect of the acetabulum.There was trunnionosis from the cobalt chrome head against the trunnion and there was significant salt formation of the neck.Cup, head, and sleeve were removed.
 
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Brand Name
ASR UNI FEMORAL IMPL SIZE 51
Type of Device
ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10321266
MDR Text Key200315323
Report Number1818910-2020-16824
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K04062
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2012
Device Catalogue Number999890251
Device Lot Number2521169
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ASR ACETABULAR CUPS 58; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT DUOFIX TAP SZ5 STD OFF; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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