MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD MID HEAD FEMORAL STEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74122158

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that a revision surgery is planned for (b)(6) 2019.Surgeon send an inquiry for a custom made insert.

Event Description

It was reported that a revision surgery was performed due to stem loosening in the left hip.Devices implanted 11 years prior.

Manufacturer Narrative

Part information updated in d1, d2 & d4 updated to better reflect event following updated case information.

Manufacturer Narrative

A bmhr head (74432052, 08bw15861 012), bmhr stem (74435430, 11062), bhr cup (74122158, 08fw17321 017) and screw (no markings present) were received for investigation following hip revision surgery.The implanted devices, were all used in treatment.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the head/cup/stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the head, stem and cup, however, these complaints are from the same patient/device.A similar complaint from a different patient has been identified for the stem and this failure will continue to be monitored.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.Visual inspection was carried out on the returned bmhr head, bmhr stem and bhr cup.A wear patch was observed on the bearing surface of the head, in diffused light.Multiple scratch grooves were also observed on the bearing surface as well as damage on the skirt.Discolouration and surface texture change on the taper of the head was noted.On the cup, fine scratches were observed on the bearing surface.Discolouration was noted on the taper of the stem.Wear analysis was performed to review linear wear on the bearing surface of the head and cup.The roundness profile for the head, showed a maximum linear wear of 7.13¿m.The roundness profile for the cup showed that the wear was low and within the manufacturing aberrations of the device.A wear patch could not be identified on the cup.Wear on the modular head taper and the stem taper could not be measured with the measuring technique used due to a lack of non-contact region.Based on historic wear data, after approximately 10.0 years in vivo, the measured linear wear on the head is line with the expected head wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.Wear on the cup was low and within the manufacturing aberrations of the devices.Due to lack of a non-contact region the depth of material loss on the head and stem tapers could not be measured.The available medical documents were reviewed.The root cause of the post-primary open reduction internal fixation (orif) surgery is a result of the patient¿s fall injury, however the cause of the fall is unknown.Review of the provided revision report did not provide any information which could explain the onset or root cause of the late infection, which resulted in the left bmhr revision approximately 10 years post orif.

• Brand Name: MID HEAD FEMORAL STEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8995775
• MDR Text Key: 157750135
• Report Number: 3005975929-2019-00325
• Device Sequence Number: 1
• Product Code: KWL
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: 74122158
• Device Catalogue Number: 74435430
• Device Lot Number: 07GW11062
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 09/04/2019; 11/06/2020
• Supplement Dates FDA Received: 04/14/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74122158, LOT # 08FW17321; MID HEAD, # 74432052, LOT # 08BW15861
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR