MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120158

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Failure to Advance (2524)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During an implantation procedure the surgeon had difficulty passing the cannulated reamer over the guide wire.The reamer ended up shearing through the guide pin and plunging out the anterior neck.As a result a competitor femoral head and stem were implanted (an off label usage) and the overall surgery time extended by around two hours.

• Brand Name: BHR ACETABULAR CUP 58MM
• 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 desantis ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6375673
• MDR Text Key: 68971666
• Report Number: 3005975929-2017-00043
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• 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
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120158
• Device Lot Number: 13MW12091
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CANNULATED DRILL, # 90127550, LOT # UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 52 YR