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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; METAL ACETABULAR LINER
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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; METAL ACETABULAR LINER Back to Search Results
Model Number 1218-87-352
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2022
Event Type  Injury  
Event Description
Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning from toxic heavy metals resulting to muscle, tissue injury, pain, metal wear, scar tissue formation, limited adl, emotional trauma and distress.Doi: (b)(6) 2007.Dor: unrevised.Left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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 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.Re-captured h6 (clinical code): metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.
 
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).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 the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays evidence were reviewed, and nothing indicative of a device nonconformance can be observed on the provided evidence, therefore the reported allegation was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b7.
 
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).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
PINNACLE MTL INS NEUT36IDX52OD
Type of Device
METAL ACETABULAR LINER
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 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14186556
MDR Text Key289867222
Report Number1818910-2022-07299
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/17/2012
Device Model Number1218-87-352
Device Catalogue Number121887352
Device Lot Number2352883
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
ARTICULEZE M HEAD 36MM +1.5.; PINNACLE SECTOR II CUP 52MM.; SUMMIT POR TAPER SZ3 HI OFF.; UNK HIP ACETABULAR LINER METAL PINNACLE.; UNK HIP FEMORAL HEAD METAL.; UNKNOWN HIP FEMORAL STEM.
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexMale
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