MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 MODULAR CATHCART BALL 46MM OD; HIP FEMORAL HEAD

Catalog Number 136346000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).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 had a hemi hip replacement for a #nof and since this has fallen and dislocated her hip which required a closed reduction.This patient has again fallen , dislocating their hip joint.The surgeon was unable to reduce the hip joint and the implants were then removed.

Manufacturer Narrative

Conclusion and justification status: the complaint states procedure: hemi hip replacement.The patient had a hemi hip replacement for a #nof and since this has fallen and dislocated her hip which required a closed reduction.This patient has again fallen , dislocating their hip joint.The surgeon was unable to reduce the hip joint and the implants were then removed.Specimens were taken to test for infection.The stem was easily removed from the cement mantle after the head and sleeve had been removed.Primary procedure (b)(6) 2017.No other supporting data is available.A complaint database search and review of manufacturing records did not identify any anomalies.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR CATHCART BALL 46MM OD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6436894
• MDR Text Key: 70967911
• Report Number: 1818910-2017-15423
• Device Sequence Number: 1
• Product Code: LZY
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136346000
• Device Lot Number: D16031340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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): Required Intervention