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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT
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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 121730500
Device Problems Corroded (1131); Fracture (1260); Metal Shedding Debris (1804); Loss of Osseointegration (2408); Malposition of Device (2616); Insufficient Information (3190)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Synovitis (2094); Discomfort (2330); Joint Swelling (2356); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 11/05/2014
Event Type  Injury  
Event Description
Patient was revised to address pain.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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
This report is still considered closed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Manufacturer Narrative
Depuy still considers this investigation closed at this time.
 
Event Description
Update 11/17/2015-pfs and medical records received.Pfs and medical records were reviewed for mdr reportability.Pfs stated injury to bone, muscle, tissue, weakness and disability.The medical records reported the acetabular shell was loose and more vertical than previously was, joint weakness/stiffness, difficulty walking, synovitis, brown fluid, brown cloudy effusion, broken screw from acetabular shell, and the femoral stem with severe corrosion at the trunnion that was revised with a crack in the calcar caused during removal of femoral stem.Medical records did not have any mention of metal debris as previously alleged.The complaint was updated on: dec 3, 2015.
 
Manufacturer Narrative
Additional narrative: examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head, liner, and bone screw.A previous review of the bone screw device history records identified no related manufacturing deviations or anomalies that would contribute to the reported event.The femoral head and liner are exempt from device history record review per procedure.No additional related reports were found against the remaining product and lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information made available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event Description
Ppf alleges fracture (bone).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 (device) product complaint # : (b)(4).Investigation summary
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> 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
PINN CAN BONE SCREW 6.5MMX30MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key4292161
MDR Text Key15323383
Report Number1818910-2014-33087
Device Sequence Number1
Product Code NDJ
Combination Product (y/n)N
PMA/PMN Number
PK983014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor,consumer,distributor,he
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/10/2010
Device Catalogue Number121730500
Device Lot NumberZS5F94000
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight75
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