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

Catalog Number 74122158

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348)

Event Date 07/17/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated metal ion levels.

Event Description

It was reported that left hip revision surgery was performed due to pain and limb length discrepancy.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain and limb length discrepancy.During revision bhr cup, bhr head and modular sleeve were revised.Synergy 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 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.The available medical documents were reviewed.According to the provided implant report, there was ¿2 to 3 mm of leg-lengthening consistent with preoperative templating¿.According to the provided revision report, the patient had elevated metal ion, pain, a shorter left leg (2.5 mm at least) and the patient was active (basketball).During the revision, significant corrosion at the sleeve neck junction was noted, which was deemed consistent with metallosis.It remains unclear form the provided documents, whether the leg-length discrepancy originated from the implantation or occurred during the time of function of the implant.A relation to the pain and the other findings cannot be further investigated.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 due to pain and limb length discrepancy.During the revision, the hemi head, bhr cup, modular sleeve and stem were removed.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 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.The available medical documents were reviewed.It was reported that left hip revision surgery was performed eight years post tha, due to pain and limb length discrepancy.A preimplantation office visit note includes acetabular dysplasia and clinical leg length discrepancy of about 1 cm short on the left as part of the patient¿s medical history.The patient was seen six months post left tha for unequal leg length discrepancy.A clinical examination revealed the left leg to be 1 cm shorter.Patient had a right tha 09/08/2016.One month post right tha clinical examination showed the right leg to be 25.0 mm (1 inch) longer based on supine medial malleolar distances.Standing alignment x-rays revealed approximately 8.0 mm difference between the right femur and left femur when measuring from the top of the acetabular prosthesis to the intercondylar notch.The patient reported left knee, left lower back, left hip and right gluteal pain.He also had an audiogram that indicated mild to severe hearing loss and other complications that required further testing to determine the underlying cause.Cobalt and chromium levels six months pre-revision were 3.3 and 1.1 ng/ml respectively.Full revision of his left hip was done 07/17/2017.The intraoperative report indicates there was significant corrosion at the sleeve/neck junction consistent with metallosis.Pathological findings were; fibroconnective tissue with chronic inflammation, pigmentladen macrophages and multinucleated giant cells with entrapped refractile material.Although the reported pain, elevated metal ions and intraoperative finding of corrosion at the sleeve/neck junction are consistent with findings associated with metallosis.The reported limblength discrepancy, hearing loss and histopathological findings of alval cannot be linked as well they cannot be concluded as a results of these mildly elevated metal ions.Based on the provided information a root cause cannot be determined nor can it be concluded that the clinical reactions are 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.

• 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: 7315657
• MDR Text Key: 101563944
• Report Number: 3005975929-2018-00071
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74122158
• Device Lot Number: 08FW17572
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71306112, LOT # 04FM08024; HEMI HEAD, # 74122552, LOT # 08GW18133; MODULAR SLEEVE, # 74222300, LOT # 08AW15191; FEMORAL STEM, # 71306112, LOT # 04FM08024; HEMI HEAD, # 74122552, LOT # 08GW18133; MODULAR SLEEVE, # 74222300, LOT # 08AW15191
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR