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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL CEM STEM STD S11; CORAIL AMT CEMENTED IMPLANTS : HIP FEMORAL STEM
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DEPUY FRANCE SAS - 3003895575 CORAIL CEM STEM STD S11; CORAIL AMT CEMENTED IMPLANTS : HIP FEMORAL STEM Back to Search Results
Catalog Number L96411
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Pain (1994)
Event Date 12/12/2023
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).G4: 510k information is not applicable.Product is no longer marketed.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
Patient was revised due to pain and aseptic loosening of femoral stem 2 years post tha.There was no surgical delay.Affected side involved in this event: left.
 
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).Investigation summary: according to the information received, ¿aseptic loosening of femoral stem 2 years post tha".The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that the fixation surface of the corail cem stem std s11 was returned devoid of cement.Additionally, signs of what appears to be gouges were found all over the proximal section of the stem, near the neck, most likely occurred during the extraction process.However, base on the available evidence, the reported condition cannot be confirmed.It is worth mentioning, that the involved ceramic head, acetabular liner and cup were retuned.However, no evidence of a device nonconformance or defects that could have contributed to the rereported event were observed.A manufacturing record evaluation was performed for the finished device [l96411 / d20120565] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the corail cem stem std s11 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation were performed for product code l96411, lot number d20120565, it was manufactured on 08-dec-2020.18pcs parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device [l96411 / d20120565] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.
 
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.
 
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Brand Name
CORAIL CEM STEM STD S11
Type of Device
CORAIL AMT CEMENTED IMPLANTS : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
Manufacturer (Section G)
DEPUY FRANCE SAS 3003895575
7 allee irene joliot curie
bp 256
saint priest cedex 69801
FR   69801
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18356537
MDR Text Key330890299
Report Number1818910-2023-25545
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K231529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/19/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberL96411
Device Lot NumberD20120565
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ALTRX NEUT 32IDX48OD; ALTRX NEUT 32IDX48OD; CORAIL CEM STEM STD S11; CORAIL CEM STEM STD S11; PINN MULTIHOLE W/GRIPTION 48MM; PINN MULTIHOLE W/GRIPTION 48MM; UNK HIP FEMORAL HEAD CERAMIC; UNK HIP FEMORAL HEAD CERAMIC; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR CUP
Patient Outcome(s) Required Intervention;
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