MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122542
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr surgery was performed on (b)(6) 2008, a revision surgery had to be conducted on (b)(6) 2021 due to metal on metal pain.A modular sleeve +8mm 12/14, a hemi head 42mm, and a acetlr cup hap 48mm w/ imptr were explanted.Patient outcome remains unknown.
Additional Manufacturer Narrative
A hemi head (details visually confirmed 74122542, 08ew17100 sn (b)(6)), acetabular cup (details visually confirmed 74120148, 086655 sn (b)(6)) and modular sleeve (details visually confirmed 74222400, 07lw14976) which were used in treatment were received for investigation following hip surgery.As of today, additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the acetabular cup, hemi head and modular sleeve was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch.However, as the device is no longer sold, no action is to be taken.No other similar complaints have been identified for the part number and the reported failure mode.The production records were reviewed for the devices involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.The =46mm bhr resurfacing system, hemi heads, sleeves have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.Visual inspection was carried out on the returned devices.A wear patch, discoloration and scratch grooves were observed on the bearing surface of the head.Fine scratches were observed on the bearing surface of the acetabular cup.Discoloration was observed on the hemi head taper.Surface texture change and discoloration were observed on the internal taper of the sleeve.No visible discoloration on the external taper of the sleeve.Wear analysis was performed to review linear wear on the bearing surface of the hemi head and acetabular cup.The wear images identified two wearing patches, one on the bearing surface of the head and one at the edge of the cup.Maximum linear wear for the head was 244.7m.On the cup maximum linear wear was 118.9m, for a combined head & cup maximum wear of 363.6m.Taper analysis was performed to review linear wear measurement results of the internal sleeve taper.The maximum depth of material loss measured from the eight vertical straightness profiles varied from 14.10 to 27.24m.The profile presents the deepest material loss of 27.24m (which is localized at the distal end of contact).Based on historic wear data, after 12.6 years in vivo, the measured combined linear wear is higher than 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 edge loading has occurred.Material loss was measured on the internal taper of the sleeve.Smith and nephew has not received adequate materials to fully evaluate the complaint.However, it should be noted, the retrieval analysis report noted linear wear is higher than the expected wear, the acetabular cup shows that edge loading has occurred, and material loss was measured on the internal taper of the sleeve.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.Internal reference number: (b)(4).

• Brand Name: HEMI HEAD 42MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12143288
• Report Number: 3005975929-2021-00351
• Device Sequence Number: 11804738
• Product Code: KWL
• UDI-Device Identifier: 00885556070710
• UDI-Public: 885556070710
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74122542
• Device Lot Number: 08FW17100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 122 KG