MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Debris, Bone Shedding (1803); Pain (1994); Synovitis (2094); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 10/17/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Due to pain, elevated cobalt and chromium levels, and right hip reactive synovitis.

Manufacturer Narrative

It was reported that right 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.The lot numbers provided for the cup and head are not valid codes.Therefore, a complaint history review, manufacturing record review, device labelling / ifu review for the cup and head cannot be performed until further information is provided.As no device batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed for the stem.If more information is received, this investigation will be reopened.A review of the complaint history for the modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.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 known 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.Prior to implantation, it was discussed with the patient that her age was outside the fda recommendations for a hip resurfacing, but she still had a very strong interest in the articulation.She was aware that this was an off-label use, however, she felt that having the metal on metal hip would be preferential to her.The risk of metal issues was discussed with her; she wished to proceed.The reported pain, elevated metal ions along with intraoperative findings of significant reactive tissue, metal staining and necrotic debris may be consistent with findings associated with metal debris and synovitis.However, use of the bhr devices outside of fda recommendations, and being off-label use, cannot be excluded as a contributing factor to the metal-related issues and need for revision.Without the analysis of the explanted components and operative reports for the left hip, the root cause of the reported pain, synovitis, and elevated metal ion levels 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.

Manufacturer Narrative

It was reported that right hip revision surgery was performed on a bilateral patient.During the revision the acetabular cup, hemi head & modular 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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a 74120154 acetlr cup 54mm, 74122548 hemi head 48mm & 74222100 modular sleeve -4mm 12/14 + a failure mode of elevated test results.Similar complaints have been identified and this failure will continue to be monitored.No lot numbers were provided; hence a documentation review could not be completed.Without the details of the devices involved in this complaint, the specific product labelling and ifus for the devices cannot be reviewed.If this information becomes available at a later time, the tasks will be reopened and completed.A risk management review was performed.No additional risks were identified as result of the reported event.The medical documents were reviewed.Although it was reported the patient had elevated metal ion levels, neither the levels nor the lab reports were provided for review.The reported pain, elevated metal ions along with intraoperative findings of significant reactive tissue, metal staining and necrotic debris may be consistent with findings associated with metal debris and synovitis.However, without the supporting lab results, imaging, and the analysis of the explanted components, the root cause of the reported pain, synovitis, and elevated metal ion levels 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: ACETABULAR CUP HAP SIZE 48/54
• 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: 8394020
• MDR Text Key: 137931184
• Report Number: 3005975929-2019-00116
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120154
• Device Catalogue Number: 74122154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71357004 ANTHOLOGY SO POR PL HA SZ 4; 74122548 HEMI HEAD 48MM; 74222300 MOD SLEEVE +4MM 12/14 08JW19038; FEMORAL STEM, # 71357004, LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOT # UNKNOWN; FEMORAL STEM, # 71357004, LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR