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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1219-32-062
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Pain (1994); Discomfort (2330); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/19/2020
Event Type  Injury  
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 Description
Surgeon reported to nca (bfarm): "hip-tep left side on (b)(6) 2013 in our hospital.Since (b)(6)2020, after a rotational movement while working in the garden, patient was experiencing increasing pain and discomfort in the left hip joint.After this, he experienced squeaking noises in the left joint plus functional restrictments and pain under load.Hip-tep right side in 3/2007; content with this one.The x-ray examination indicated a dislocated inlay of the hip-tep on the left.Revision of left hip-tep on (b)(6) 2020.".
 
Event Description
On (b)(6) 2020 the patient was revised for left hip tilted, dislocated cup insert (disassociation).The liner and cup was revised.Cup insert appears tilted and rotated, now opening in a lateral direction, resulting in impingement of the head at the lateral acetabular margin.
 
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.H6 health effect clinical code - appropriate term/code not available (e2402) is used to capture joint injury.
 
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: d10 concomitant med products.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 : examination of the returned device along with the attached x-ray images confirmed a disassociation event.Error in materials or manufacture was not identified.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 : dhr has been reviewed and no deviations or anomalies were found.
 
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Brand Name
PINN MAR NEUT 32IDX62OD
Type of Device
PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10808928
MDR Text Key215294448
Report Number1818910-2020-24169
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295013952
UDI-Public10603295013952
Combination Product (y/n)N
PMA/PMN Number
K983014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/22/2020
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
Device Operator Health Professional
Device Model Number1219-32-062
Device Catalogue Number121932062
Device Lot Number307238
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Initial Date Manufacturer Received 10/22/2020
Initial Date FDA Received11/09/2020
Supplement Dates Manufacturer Received11/23/2020
12/01/2020
12/14/2020
01/14/2021
01/19/2021
Supplement Dates FDA Received11/30/2020
12/16/2020
12/21/2020
01/18/2021
01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 13; DELTA CER HEAD 12/14 32MM +9; PINNACLE 100 ACET CUP 62MM; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient Age81 YR
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