MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problems Metal Shedding Debris (1804); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

It was reported that revision surgery is scheduled for (b)(6) 2017.Patient reports pain and elevated levels of cobalt in the blood.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision the cup, hemi head and sleeve were removed.The stem remained implanted.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 bhr cup, hemi head and modular sleeve 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 and hemi head.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.The available medical documents were reviewed.The reported pain, elevated metal ions and intraoperative findings of fluid collection and corrosion may be consistent with findings associated with metal debris; however, the root cause of the pain, elevated metal ions, fluid collection and corrosion cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision and expected transient post-op convalescence period cannot be determined.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.

• Brand Name: BHR ACETABULAR CUP 56MM
• 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: 6998808
• MDR Text Key: 90946165
• Report Number: 3005975929-2017-00389
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

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 Expiration Date: 08/31/2013
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 092688
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 10/31/2017; 09/04/2020
• Supplement Dates FDA Received: 08/23/2018; 09/04/2020
• Patient Sequence Number: 1
• Treatment: 71309016 SYN POR PLUS HA SO ST SZ 16 08JM11903A; 71309016/SYN POR PLUS HA SO STEM SZ 16/UNKNOWN; 74122550 HEMI HEAD 50MM 08KW19416; 74122550/HEMI HEAD 50MM/UNKNOWN; 74222200 MOD SLEEVE PLUS 0MM 12/14 08FW17516; 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14/UNKNOWN; FEMORAL HEAD, # 74121150, LOT # UNKNOWN; FEMORAL HEAD, # 74121150, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention