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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 56OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 56OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121881756
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).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
It was reported that fractured ceramic hip inlay.
 
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: a2 (dob), d6a, d6b if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b5, h6 (health effect- impact code).
 
Event Description
Additional information received stated that there was a 50-60 minutes surgical delay due to the retrieval of ceramic fragments and rinsing of the surgical area.Doi: (b)(6) 2022 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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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 : bfarm dhr review product description: delta cer insert 36id x 56od product code: 121881756, lot number: 8789716.1) quantity manufactured:(b)(4).2) date of manufacture: 18/04/2018 3) any anomalies or deviations identified in dhr: no 4) expiry date: 31/03/2023 5) ifu reference: 78002788.Device history review : the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.
 
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: d4 (lot) 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.
 
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Brand Name
DELTA CER INSERT 36ID X 56OD
Type of Device
PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthpaedic dr.
warsaw, IN 46581
3035526892
MDR Report Key15949156
MDR Text Key305142672
Report Number1818910-2022-24856
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeGM
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 12/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number121881756
Device Lot Number8789716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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