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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT44IDX62OD; HIP ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT44IDX62OD; HIP ACETABULAR LINERS Back to Search Results
Catalog Number 121887462
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Discomfort (2330); Metal Related Pathology (4530); Swelling/ Edema (4577)
Event Date 04/13/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: consumer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Revision completed due to patient developing a large pseudotumor.Patient started to complain of pain and swell.Mrs showed the pseudotumor.All components were removed.Doi: 2010; dor: (b)(6) 2022; affected side: right hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: update 17 jun 2022 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) will not be performed since mom systems are obsolete.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
Event Description
In addition to what previously alleged, patient alleges discomfort and fall.
 
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.E3 initial reporter occupation: lawyer.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: update (b)(6) 2022.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) will not be performed since mom systems are obsolete.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
 
Event Description
Litigation and medical records received.Litigation records has no new allegation reported.After review of medical records no revision notes were reported.In addition to what was previously alleged, the patient alleged metallosis.
 
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: h6: appropriate term / code not available (e2402) is being utilized to capture hypersensitivity/allergic reaction.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Litigation records received alleged heavy metal poisoning.
 
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.E3 initial reporter occupation: lawyer.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 : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
 
Event Description
Medical records were received and stated that on (b)(6) 2022, patient had a revision for right total hip replacement due to metallosis and localized fluid collection.Operative reported a darkish staining of metallic wear debris noted in anterior portion of acetabular device.
 
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.H10 additional narrative: added: b5, h6 health effect - clinical code if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Medical records received.Patient was revised due to the following pathologic findings: cyst, corrosion; metallosis.There was metallic staining at the base of the trunnion.
 
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Brand Name
PINNACLE MTL INS NEUT44IDX62OD
Type of Device
HIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds IN LS11 8DT
UK   LS11 8DT
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14592447
MDR Text Key293265531
Report Number1818910-2022-10033
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2012
Device Catalogue Number121887462
Device Lot Number2450206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/15/2022
Initial Date FDA Received06/03/2022
Supplement Dates Manufacturer Received06/06/2022
06/17/2022
07/01/2022
07/15/2022
07/22/2022
07/26/2022
11/15/2022
03/01/2023
03/20/2023
08/17/2023
Supplement Dates FDA Received06/07/2022
06/17/2022
07/14/2022
07/18/2022
07/25/2022
07/27/2022
11/18/2022
03/07/2023
03/20/2023
08/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 12/14 44 +1.5; PINNACLE 300 ACET CUP 62MM; SUMMIT POR TAPER SZ8 HI OFF; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient SexMale
Patient Weight87 KG
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