MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 PINN CAN BONE SCREW 6.5MMX15MM; HIP OTHER IMPLANT

Catalog Number 121715500

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 02/23/2015

Event Type  Injury  

Manufacturer Narrative

The complaint states patient was revised to address acetabular cup loosening.It was noted that the cup had become loose due to a hole on the anterior medial side of the cup.A complaints database search and review of manufacturing records did not identify any anomalies.Without further information or return of products the root cause of the complaint cannot be confirmed.The complaint shall be closed with an undetermined conclusion and entered into the complaint database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.No further actions are identified.Post market surveillance is per sep (b)(4).

Event Description

Patient was revised to address acetabular cup loosening.It was noted that the cup had become loose due to a hole on the anterior medial side of the cup.

Manufacturer Narrative

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.

• Brand Name: PINN CAN BONE SCREW 6.5MMX15MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 2151 2-6; CH 21512-6
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 2151 2-6; CH 21512-6
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4592206
• MDR Text Key: 13282974
• Report Number: 1818910-2015-15912
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

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: 01/31/2024
• Device Catalogue Number: 121715500
• Device Lot Number: D13120942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 03/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• 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: 70 YR