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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE; METAL ACETABULAR LINER
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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE; METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER METAL
Device Problem Naturally Worn (2988)
Patient Problems Fever (1858); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/06/2021
Event Type  Injury  
Event Description
Pinnacle mom litigation records received.Litigation alleges revision due to heavy metal poisoning from toxic metals resulting to pain, pseudotumor, trunnionosis, tissue destruction, metal wear, loss of enjoyment of life, limited adl, emotional trauma and distress.Doi: (b)(6) 2006, dor: (b)(6) 2021, hip unknown.
 
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) 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.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.
 
Event Description
Medical records received.On (b)(6) 2021, the patient was revised due to right total hip revision femoral head and liner exchange possible acetabular revision.The patient has a long history of severe pain secondary to metallosis after a two-stage revision in 2006.The patient has a history of primary in 2004.After the revision of 2006, about 5 to 6 months the patient was evaluated and found to have pseudotumor confirmed in mri as well elevated metal ion levels.Prior to 2 days, the patient developed confusion and fever, found with staph bacteremia, with aspiration the right hip showed a gram-positive cocci growing from early cultures.Surgical noted trunnion was evaluated with metallosis at the grooves.The patient had previously infected hip arthroplasty in 2004 but it was an unknown manufacturer.These devices were replaced with a pinnacle hip in 2006.No implant stickers were provided for the dated right total arthroplasty on (b)(6) 2006.
 
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.
 
Event Description
Medical records were received and stated the following: on (b)(6)2021: incision and drainage of shoulder deep abscess and hematoma with left shoulder myolitis with incomplete collection.On (b)(6)2021.Patient was revised due to right total hip arthroplasty painful metallosis with superimposed concern for periprosthetic infection.Also reported of cobalt 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.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.Review of the x-ray evidence found nothing indicative of a device nonconformance.No signs of implant bearing wear were observed.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 records evaluation (mre) was not performed as no lot number was provided for this 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.
 
Event Description
Affected side: right hip.
 
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Brand Name
UNK HIP ACETABULAR LINER METAL PINNACLE
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 Key14250305
MDR Text Key290379415
Report Number1818910-2022-07867
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 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
SROM UNK HIP FEMORAL STEM SROM; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL SLEEVE SROM; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient SexMale
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