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

Model Number 74122158

Device Problems Fracture (1260); Pitted (1460)

Patient Problems Host-Tissue Reaction (1297); Debris, Bone Shedding (1803); Inflammation (1932)

Event Date 03/06/2014

Event Type  Injury  

Event Description

Left hip revision surgery was performed due to component mobilisation and adverse local tissue reaction.Mri had shown fluid collection, which was negative for infection upon aspiration.Fracture of greater trochanter noted during procedure with additional cable fixation required.All components revised.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup, head, sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup, head and stem.Similar complaints were identified for the sleeve and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The medical records were reviewed.The clinical information provided, of the corrosion of the trunnion, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The impact to the patient beyond the revision surgery cannot be determined with the provided information.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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• 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: 8618905
• MDR Text Key: 145340748
• Report Number: 3005975929-2019-00211
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

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 Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 08KW19765
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 05/07/2020
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71356106, # 07HM07348; HEMI HEAD, # 74122552, LOT # 08CW16141; MODULAR SLEEVE, # 74222300, LOT # 9768; FEMORAL STEM, # 71356106, # 07HM07348; HEMI HEAD, # 74122552, LOT # 08CW16141; MODULAR SLEEVE, # 74222300, LOT # 9768
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR