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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM; HIP OTHER IMPLANT
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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 121735500
Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544)
Event Date 10/18/2013
Event Type  Injury  
Event Description
Litigation alleges the patient suffers from pain, difficulty ambulating, signs of loosening, infection and metallosis.At the (b)(6) 2013 revision, an antibiotic spacer was placed.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Manufacturer Narrative
No device associated with this report was received for examination.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
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
Update rec'd 7/24/2014-pfs and medical records received.After review of the medical records the revision operative note confirmed infection.There was no mention of metallosis.The patient had spacers removed and reimplanted on (b)(6) 2014.There is no new additional information that would affect the existing mdr decision.
 
Manufacturer Narrative
The devices associated with this report were not returned.A complaint database search found other reported incidents against the provided product and lot combinations.Per wi-3430, revision c, a review of the device history records is no longer required for these products.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not 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
Update sep 7, 2017: pfs and medical records received.In addition to what was previously alleged, pfs alleges antalgic gait.After review of the medical records for the mdr reportability, in addition to what was previously alleged, x-ray showed a cementless right thr with some evidence of loosening around the femoral component.Mri reported of mild edema.Culture and sensitivity reported of rare growth of (b)(6).Surgical pathology reported of chronic inflammatory infiltrates.Laboratory result for cobalt is above 7 mcg/l.This complaint was updated on sep 27, 2017.
 
Manufacturer Narrative
(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Udi: (b)(4).Ds8em4000.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
PINN CAN BONE SCREW 6.5MMX35MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key3786336
MDR Text Key4441125
Report Number1818910-2014-17944
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 Other,consumer,other
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number121735500
Device Lot NumberDS8EM4000
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient Weight68
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