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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT
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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 121725500
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003); Insufficient Information (3190)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 03/10/2014
Event Type  Injury  
Event Description
Litigation alleges the patient suffers from pain, swelling, inflammation and infection.Update rec'd (b)(6) 2014 - pfs and medical records received.Part/lot information provided.A correct doi and dor was provided.After review of the medical records the patient had a poly liner implanted so the other implants besides the head and liner cannot be excluded as the cause the pain.All other implants are being added to the complaint.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2014.
 
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
The devices associated with this report were not returned.A review of the device history records for the cc6ls4000 lot code did not reveal any related manufacturing deviations or anomalies.A complaint database search finds no other reported incidents against the remaining product and lot combinations.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.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.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4).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 caused or contributed to the potential event described in this report.No code available use for medical device removal.
 
Event Description
Ppf alleges dislocation (open and closed reduction).After review of medical records, it was stated that the patient was revised to address asceptic loosening of the stem; however, exact loosening interface was not specified.Revision notes reported that the stem was noted to be grossly loose; there was significant subsidence prior to removing the stem; and mild wear noted in the cup.There was no evidence of infection and acetabular component was not loose.There was also no confirmed dislocation and no noted wear in the head and liner.Prior to admission, pain, difficulty in movement, weakness, walking difficulty and swelling in the ankle were noted.Depuy devices were implanted in the acetabular side but non-depuy were implanted in the femoral side.Added account name.Corrected age and weight of patient.Updated patient harm.Doi: (b)(6) 2008; dor: (b)(6) 2012 right hip.
 
Event Description
Ppf alleges loosening of cup and stem, metal wear, metallosis and elevated metal ions.
 
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 caused or contributed to the potential event described in this report.Udi: (b)(4).
 
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 CAN BONE SCREW 6.5MMX25MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key3895645
MDR Text Key4539527
Report Number1818910-2014-22033
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,other
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number121725500
Device Lot NumberCC6LS4000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2014
Initial Date FDA Received06/25/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
09/11/2019
12/16/2019
07/06/2020
Supplement Dates FDA Received06/26/2014
12/18/2014
09/26/2019
12/27/2019
07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age49 YR
Patient Weight204
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