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

Model Number 74122158

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Muscle Weakness (1967); Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414); Test Result (2695)

Event Date 12/10/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain, metallosis with metal debris, abductor muscle damage, elevated chromium and cobalt levels, systemic effects, and adverse local tissue reaction.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr 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 have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, modular 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 stem.Similar complaints have been identified for the bhr cup.This will continue to be monitored.Similar complaints have been identified for the hemi head and modular sleeve.However, as the devices are 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 and no further actions are required at this time.The available medical documents were reviewed.The reported adverse local tissues reaction and elevated cocr levels may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the information provided.Without supporting lab/pathology results, pre and post-radiographic images, and/or the analysis of the explanted components, the root cause of the reported clinical symptoms cannot be concluded and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and associated post-op pain 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.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr 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 have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi 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 stem.Similar complaints have been identified for the bhr cup.This will continue to be monitored.Similar complaints have been identified for the hemi head and sleeve.However, as the devices are 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 and no further actions are required at this time.The available medical documents were reviewed.The reported adverse local tissue reaction and elevated cobalt and chromium levels may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the information provided.Without supporting pre and postradiographic images, and/or the analysis of the explanted components, the root cause of the reported dislocation and clinical symptoms cannot be concluded and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and associated post-op pain 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 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: 8978764
• MDR Text Key: 157034045
• Report Number: 3005975929-2019-00317
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 08KW19771
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Patient Sequence Number: 1
• Treatment: 71306114 SYN POR HO FEM COM SZ 14 09CM23084; 74122552 HEMI HEAD 52MM 08GW18134; 74222200 MOD SLEEVE {} PLUS 0MM 12/14 08CW16017; FEMORAL STEM, # 71306114, LOT # UNKNOWN; HEMI HEAD, # 74122552, LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, # LOT UNKNOWN; FEMORAL STEM, # 71306114, LOT # UNKNOWN; HEMI HEAD, # 74122552, LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, # LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention