MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122150

Device Problems Unstable (1667); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Local Reaction (2035); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/16/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Pain, loss of mobility, local tissue reaction, dislocation, leg length discrepancy, elevated metal ion levels, joint instability inflammation and soreness around the implant reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

[(b)(4)].

• Brand Name: BHR ACETABULAR CUP 50MM
• 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: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6927963
• MDR Text Key: 88756985
• Report Number: 3005975929-2017-00355
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 74122150
• Device Lot Number: 11DW00779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2017
• Date Device Manufactured: 03/19/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR