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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 PINN CAN BONE SCREW 6.5MMX20MM; HIP OTHER IMPLANT

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JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 PINN CAN BONE SCREW 6.5MMX20MM; HIP OTHER IMPLANT Back to Search Results
Catalog Number 121720500
Device Problem Loss of Osseointegration (2408)
Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Date 03/29/2016
Event Type  Injury  
Manufacturer Narrative
Additional narrative: (b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
(b)(4).Patient in the year 2003 was subjected to a right hip arthroplasty in which received an asr implant.Due to mobilisation of the implant, the patient was subjected to a revision surgery ((b)(6) 2013) in which was implanted a pe/ceramic implant.Following this revision the patient accused pain and difficult in dehambulating.Subsequent examination detected a mobilisation of the implants and metallosis with cr level ions of 04 microg./l update rec'd 27 april 2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient has a loose acetabular component.At this time, the patients cup and screws are being reported for loosening.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy still 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.
 
Manufacturer Narrative
Depuy still 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
Update 20-apr-2017: medical records received.After review of the medical records for mdr reportability, the medical records indicated a wound infection in (b)(6) 2014.Cup loosening was also mentioned in (b)(6) 2014.The patient was revised on (b)(6) 2015 for infection.All implants were removed and spacers were placed.Revision operative note wasn't provided so it¿s unknown if loosening and metallosis was found at revision.No labs were provided for the alleged high metal ion levels (labs were provided after the revision).Part/lot is being updated for the stem and the stem is now being reported.
 
Manufacturer Narrative
Depuy16-12.Patient in the year 2003 was subjected to a right hip arthroplasty in which received an asr implant.Due to mobilisation of the implant, the patient was subjected to a revision surgery ((b)(4) 2013) in which was implanted a pe/ceramic implant.Following this revision the patient accused pain and difficult in deambulating.Subsequent examination detected a mobilisation of the implants and metallosis with cr level ions of 04 microg./l update rec'd (b)(4) 2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient has a loose acetabular component.At this time, the patients cup and screws are being reported for loosening.The complaint was updated on: (b)(4) 2016.Update (b)(4) 2017: medical records received.After review of the medical records for mdr reportability, the medical records indicated a wound infection in (b)(4) and (b)(4) of 2014.Cup loosening was also mentioned in (b)(4) of 2014.The patient was revised on (b)(4) 2015 for infection.All implants were removed and spacers were placed.Revision operative note wasn't provided so it¿s unknown if loosening and metallosis was found at revision.No labs were provided for the alleged high metal ion levels (labs were provided after the revision).Part/lot is being updated for the stem and the stem is now being reported.This complaint was updated on: (b)(4) 2017.Update (b)(4) 2017: additional information received.Updated date of implant.This complaint was updated on (b)(4) 2017.Update (b)(4) 2017: additional information received.Updated date of implant.This complaint was updated on (b)(4) 2017.The reported event has been evaluated and will be monitored.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.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 6.5MMX20MM
Type of Device
HIP OTHER IMPLANT
Manufacturer (Section D)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou 21512 -6
CH  21512-6
Manufacturer (Section G)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou 21512 -6
CH   21512-6
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key5680014
MDR Text Key45956244
Report Number1818910-2016-20006
Device Sequence Number1
Product Code NDJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK983014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/26/2016
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? No
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Catalogue Number121720500
Device Lot NumberD12090053
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/26/2016
Initial Date FDA Received05/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
11/30/2017
12/12/2017
Supplement Dates FDA Received06/14/2016
05/15/2017
12/11/2017
01/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
Patient Weight81
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