MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Loose or Intermittent Connection (1371); Naturally Worn (2988); Unintended Movement (3026)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/09/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to loosening.

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

Additional information image or date of birth, sex, weight, brand name, operator of device, concomitant medical products.It was reported that a revision surgery was performed due to loosening involving the following devices 74120152 bhr cup, 74222146 birmingham hip modular head (bhmh), and modular sleeve (size unknown).No details about the related femoral stem have been received.A modular head (741222146, 09cw22240 sn: 0** *number obscured due to scratch), sleeve (details obscured due to engagement) and bhr cup (74120152, 95647 sn (b)(4)) were returned for analysis to smith & nephew.All the known birmingham hip modular head and bhr cup devices involved met manufacturing specifications at the time of production.Manufacturing review for the sleeve and stem reportedly involved in this complaint could not be carried out due to a lack of part & lot / batch information.Visual inspection was performed on the returned devices.Fine scratches were observed on the bearing surface of the modular head.Fine scratches were observed on the bearing surface of the bhr cup.Surface texture change and discolouration were observed on the internal sleeve taper.Wear analysis was performed to review linear wear on the bearing surface of the modular head, bhr cup and sleeve.The wear image for the modular head showed a wear patch on the bearing surface.The wear image for the bhr cup showed a wear patch on the bearing surface.The maximum linear wear for the modular head was 10.8m.The maximum linear wear for the bhr cup was 8.9 ¿m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 24.8 m.The measured combined linear wear is 19.7 m on the bearing surface.Based on historic wear data, after 9.1 years in vivo, the measured combined linear wear is in line with the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.Material loss was measured on the internal taper of the sleeve.The available medical documents were reviewed.The revision operative notes document; ¿the bursa trochanteric is clearly blackened - metal particles penetrated into the soft tissues, a radical bursectomy is needed¿ - ¿the entire hip capsule is thickened fibrous¿ ¿very tedious to undergo a radical en bloc resection and to completely remove the metallosis from the body¿ ¿corrosion has also occurred in the area of the intermediate adapter¿ also.¿removal of the osteophytes¿ four (4) x-rays were submitted for review, which does not show any notable changes between the 2009 post-implant and the 2018 pre-revision.The clinical information provided, of the bursa trochanteric blackened and metal particles penetrating into the soft tissues and loosening and the histological review of the biopsy confirm a metallosis reaction.However the source cannot be determined with the available documentation.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 become 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, but are available to be returned if requested.

• Brand Name: ACETLR CUP HAP 52MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 8045237
• MDR Text Key: 126348325
• Report Number: 3005975929-2018-00425
• Device Sequence Number: 1
• Product Code: NXT
• 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,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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 Catalogue Number: 74120152
• Device Lot Number: 95647R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71309013, LOT# UNKNONW; 74222146, LOT# 09CW22240; 74222200, LOT# UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80