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

Catalog Number 74122158

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)

Event Date 11/12/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to generalised pain, with swelling and decreased range of motion.

Manufacturer Narrative

[(b)(4)].

Manufacturer Narrative

Additional: age or date of birth.It was reported that right hip revision surgery was performed.During the revision, the hemi head, modular sleeve & acetabular cup were removed.The stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.In conclusion, the year long delayed revision cannot be ruled out as a contributory factor to the reported pain.Intraoperative findings were erosion and debris.However, without the supporting lab results, imaging and the analysis of the explanted components, the source of reactions cannot be confirmed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.Correction concomitant medical products.

• 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
• MDR Report Key: 7056651
• MDR Text Key: 92832296
• Report Number: 3005975929-2017-00403
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 74122158
• Device Lot Number: 10JW30086
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 11/15/2017; 11/15/2017
• Supplement Dates FDA Received: 01/19/2018; 10/27/2019
• Patient Sequence Number: 1
• Treatment: 74222200/MODULAR SLEEVEPLUS 0MM12/14/10CT40483; FEMORAL STEM, # 71306112, LOT # 10LM15867; FEMORAL STEM, # 71306112, LOT # NI; HEMI HEAD, # 74122552, LOT # 10CW09244; HEMI HED, # 74122552, LOT # NI; MODULAR SLEEVE, # 74222100, LOT # 10CT40483; MODULAR SLEEVE, # 74222100, LOT # NI
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR