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

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.

• 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 Key: 5680014
• MDR Text Key: 45956244
• Report Number: 1818910-2016-20006
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• 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 Date: 01/31/2023
• Device Catalogue Number: 121720500
• Device Lot Number: D12090053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/30/2017; 12/12/2017
• Supplement Dates FDA Received: 06/14/2016; 05/15/2017; 12/11/2017; 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 81