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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-30-052
Medical Device Problem Codes Use of Device Problem (1670); Loss of Osseointegration (2408); Malposition of Device (2616)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 05/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the cup alignment is causing pain.It was also indicated that there was a loosening of the cup at bone to implant interface.Doi: (b)(6) 2019.Dor: (b)(6) 2020; left side.
 
Additional 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.H10 additional narrative: corrected: h6 (device).
 
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Brand Name
PINN MULTIHOLE W/GRIPTION 52MM
Common Device Name
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10109205
Report Number1818910-2020-13004
Device Sequence Number11448382
Product Code LPH
UDI-Device Identifier10603295009986
UDI-Public10603295009986
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K071784
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/20/2020
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? Yes
Operator of Device Health Professional
Device Model Number1217-30-052
Device Catalogue Number121730052
Device Lot NumberJ0661X
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/20/2020
Supplement Date Received by Manufacturer07/13/2020
Initial Report FDA Received Date06/02/2020
Supplement Report FDA Received Date07/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ALTRX NEUT 36IDX52OD.; BONE SCREW.; PINN MULTIHOLE W/GRIPTION 52MM.; UNKNOWN HIP FEMORAL HEAD.; ALTRX NEUT 36IDX52OD; BONE SCREW; PINN MULTIHOLE W/GRIPTION 52MM; UNKNOWN HIP FEMORAL HEAD
Outcome Attributed to Adverse Event Required Intervention;
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