MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122150

Device Problems Corroded (1131); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Toxicity (2333); No Code Available (3191)

Event Date 03/08/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain, femoral neck thinning and elevated metal ions.

Manufacturer Narrative

A bmhr head (74432044, 07hw13069 sn(b)(4)), a bhr cup (74122150, 07lw14700(b)(4) ), and a bmhr stem (74431312, 08kw19561) were received for investigation following a reported hip revision surgery for pain, femoral neck thinning and elevated metal ions.Visual inspection was performed on the returned devices.On the bmhr head fine scratches were observed on the bearing surface of the head under normal lighting conditions and a wear patch could be observed when light was diffused.On the bhr cup fine scratches were observed on the bearing surface.For the bmhr stem some damage was noted.For the internal bmhr head taper and external bmhr stem taper surface texture change and discolouration were observed.Wear analysis was performed to review linear wear on the bearing surface of the bmhr head and bhr cup.The wear images identified two wear patches on the bearing surface of the head and two wear patches on the bhr cup.The maximum linear wear for the bmhr head was 27.4 ¿m.The maximum linear wear for the bhr cup was 20.7¿m, for a combine head and cup maximum wear of 48.1¿m.Depth of the material loss on the tapers of the bmhr head and bmhr stem couldn¿t be measured due to a lack of a non-contact area for reference.Based on historic wear data, after 10.2 years in vivo, the measured combined linear wear on the bearing surface is higher than the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.Multiple wear patches were measured on the cup and the head.Surface texture change and discolouration were observed on head and stem taper, however, depth of materials loss could not be measured due to lack of non-contact area for reference the available medical documents and explant analysis were reviewed.The clinical information provided, of the pain, femoral neck thinning, elevated metal ion levels and the pseudotumour may be consistent with a reaction to metal debris.However the source and the root cause cannot be determined with the available documentation and could be related to corrosion at the trunnion or also possible edge loading but if this is due to migration of the shell versus the implantation position cannot be concluded.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The devices will be retained and will be available for return upon request.

• Brand Name: BHR ACETABULAR CUP 50MM
• 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: 8412654
• MDR Text Key: 138539983
• Report Number: 3005975929-2019-00130
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74122150
• Device Lot Number: 07LW14700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR HEAD, # 74432044, LOT # 07HW13069; MODULAR STEM, # 74431312, LOT # 08KW19561; MODULAR HEAD, # 74432044, LOT # 07HW13069; MODULAR STEM, # 74431312, LOT # 08KW19561
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR