MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 MODULAR CATHCART BALL 44MM OD; HIP FEMORAL HEAD

Catalog Number 136344000

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address pain.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed.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.

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should the 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.

Event Description

Update aug 14, 2017: additional information received.The summit basic stem loose.Loosening occurred from bone to implant interface.This complaint was updated on aug 15, 2017.

• Brand Name: MODULAR CATHCART BALL 44MM OD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou IN 21512 -6; CH 21512-6
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou IN 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6731268
• MDR Text Key: 80630885
• Report Number: 1818910-2017-21449
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032762
• UDI-Public: 10603295032762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136344000
• Device Lot Number: D16040572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 74