MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122152

Device Problems Material Too Rigid or Stiff (1544); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that revision surgery was performed.The devices were implanted in 2008.In 2016 the customer started experiencing reported severe pain in her left hip.A ct scan was performed and x-rays were taken.During surgery the surgeon excluded infection by means of a synovasure test.There was minimal evidence of metallosis.The cup was well fixed and it was evident that the neck was sclerotic.

• Brand Name: BHR ACETABULAR CUP 52
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5932118
• MDR Text Key: 54041205
• Report Number: 3005975929-2016-00003
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74122152
• Device Lot Number: 07HW13116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART # 74123144, LOT # 5749 008
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 45 YR