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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; METAL ACETABULAR LINER Back to Search Results
Model Number 1218-87-456
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/18/2021
Event Type  Injury  
Manufacturer Narrative
(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.
 
Event Description
(b)(6) litigation received.Patient alleges pain, elevated metal ion, metal debris, pseudotumor, injury, tissue destruction, bone destruction, and emotional distress.Doi: (b)(6) 2011; dor: (b)(6) 2021; (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) will not be performed since mom systems are obsolete.
 
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Brand Name
PINNACLE MTL INS NEUT40IDX56OD
Type of Device
METAL ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds IN LS11 8DT
UK   LS11 8DT
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14084168
MDR Text Key289071750
Report Number1818910-2022-06586
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 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2015
Device Model Number1218-87-456
Device Catalogue Number121887456
Device Lot Number3188478
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2010
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
12/14 ARTICUL 40MM M SPEC+5; PINN 100 W/GRIPTION 56MM; SUMMIT POR TAPER SZ6 HI OFF; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient SexMale
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