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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM; HIP OTHER IMPLANT
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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 121720500
Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804)
Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Necrosis (1971); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 05/29/2013
Event Type  malfunction  
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
Patient was revised to address pain and osteolysis.Update rec'd (b)(4) 2014- pfs and medical records received.Part/lot was provided.The doi was provided.Revision operative notes indicated metallosis, tissue/bone necrosis, a loose cup, and an acetabulum fracture.The head and screw are now being reported.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(4) 2014.
 
Manufacturer Narrative
The devices associated with this report were not returned.A complaint database search finds no other related incidents against the provided 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.
 
Event Description
Patient was revised to address pain and osteolysis.Update rec'd (b)(4) 2014- pfs and medical records received.Part/lot was provided.The doi was provided.Revision operative notes indicated metallosis, tissue/bone necrosis, a loose cup, and an acetabulum fracture.The head and screw are now being reported.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(4) 2014.New unity record created in order to update etq complaint number com-(b)(4).Update (b)(4) 2018: com-(b)(4) has been re-opened under pc-000247940 due to receipt of ppf and sticker sheets received.In addition to what were previously alleged, ppf alleges loosening of cup, loosening of stem and coponent fracture.Added stem in impacted products.Doi: (b)(4) 2009-dor: (b)(4) 2013 (left hip).
 
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.
 
Event Description
Patient was revised to address pain and osteolysis.Update rec'd 2/4/2014- pfs and medical records received.Part/lot was provided.The doi was provided.Revision operative notes indicated metallosis, tissue/bone necrosis, a loose cup, and an acetabulum fracture.The head and screw are now being reported.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 03/04/14.New unity record created in order to update etq complaint number (b)(4).Update 31 july 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets received.In addition to what were previously alleged, ppf alleges loosening of cup, fracture and loosening of stem.Added stem in impacted products.Doi: (b)(6) 2009 : dor: (b)(6) 2013 (left hip).
 
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Brand Name
PINN CAN BONE SCREW 6.5MMX20MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key3658397
MDR Text Key19796841
Report Number1818910-2014-13642
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/14/2019
Device Catalogue Number121720500
Device Lot NumberDJ4AX4000
Was Device Available for Evaluation? No
Date Manufacturer Received09/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight71
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