MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HI-LUBRIMET SHELL 7; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 75001023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Metal Related Pathology (4530)

Event Date 07/03/2020

Event Type  Injury  

Event Description

It was reported that after 14 years of primary procedure, revision with acetabular reconstruction using a ¿ganz-hakendachs shell¿ and trabecular metal augments combined with an uncemented, modular conical revision stem.Three s+n devices were explanted.

Manufacturer Narrative

It was reported that 14 years after the implantation, a revision surgery was performed on the left hip due to signs of metalosis.Pre-revision cobalt and chromium ion levels were 214nmol/l each.However, a detailed assessment of cognitive functions did not document any deficits that could be attributed to cobalt or chromium intoxication.The removed devices, a hi cup, metal insert, metal ball head and an sl stem, used in treatment, were returned for investigation.The liner was disassembled from the cup and the ball head was removed from the stem after the reception of the patient's consent.Furthermore, it was reported that the right hip was revised as well, captured under (b)(4).The liner shows some minor scratches on the contact area with the ball head.The ball head shows a similar pattern.The shell shows some minor signs of use.The stem has some major scratches on the surface, which most likely originate from the explantation procedure.The cone of the stem shows discoloration on the surface.A technical evaluation was conducted.The linear wear of the ball head and the liner were assessed using a roundness machine for the head and a surface profiler for the cup.The linear wear on the ball head was measured to be 54.2 ¿m, the linear wear on the liner was 53.0 ¿m (combined 107.2 ¿m, 7.6 ¿m/year).The volumetric wear could only be assessed for the ball head and resulted in 20.6 mm3.The presence of a marked wear patch on the acetabular liner shows that edge loading has occurred.Taper analysis for the linear wear of the ball head measured the maximum depth of material loss measured at 56.1 ¿m.A production documentation of all four implants, including the material certificates, did not show any deviation.The certificates demonstrate that the raw material is a wrought cobalt-chromium-molybdenum alloy as specified in the product files.There are no indications that the parts failed to match specification at the time of manufacturing.A complaint history was conducted and is was shown that the reported failure mode are covered by the risk management file in severity and occurrence.The combination of the devices was approved by smith and nephew.The ball head and the liner are no longer available on the market.According to the ifu versions, lit no.12.23, ed.09/05 and lit no.12.07, ed.01/03 is abrasion of implant surfaces and development of osteolysis as a reaction to foreign bodies a possible side effect for a hip arthroplasty.Based on the received information a medical assessment was conducted.It is stated, that the inclination of the cup is pretty flat with about 24 degrees (date is unknown).The available radiographs are undated, hence the evolution of the cup inclination over the 14 year in vivo period cannot be evaluated.The provided medical information confirms the reported blood cobalt ion level of 214 nmol/l and chromium ion level of 214nmol/l.With the information provided the root cause of the reported osteolysis cannot be determined, however edge loading cannot be ruled out as a contributing factor.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined; based on this investigation, the loosening of the cup can be seen as a result of metalosis, however, the reported fall could also accelerate wear an lead to metal debris and result in metalosis.The devices in questions are no longer available on the market.The need for further actions is not indicated.Smith and nephew will monitor these devices for further similar issues.The returned devices will be retained.

Manufacturer Narrative

It was reported that 14 years after the implantation, a revision surgery was performed on the left hip due to signs of metalosis.Pre-revision cobalt and chromium ion levels were 214nmol/l each.The removed devices, a hi cup, metal insert, metal ball head and an sl stem, used in treatment, were returned for investigation.The liner was disassembled from the cup and the ball head was removed from the stem after the reception of the patient's consent.Furthermore, it was reported that the right hip was revised as well, captured under (b)(4).The liner shows some minor scratches on the contact area with the ball head.The ball head shows a similar pattern.The shell shows some minor signs of use.The stem has some major scratches on the surface, which most likely originate from the explantation procedure.The cone of the stem shows discoloration on the surface.A technical evaluation was conducted.The linear wear of the ball head and the liner were assessed using a roundness machine for the head and a surface profiler for the cup.The linear wear on the ball head was measured to be 54.2 ¿m, the linear wear on the liner was 53.0 ¿m (combined 107.2 ¿m, 7.6 ¿m/year).The volumetric wear could only be assessed for the ball head and resulted in 20.6 mm3.The presence of a marked wear patch on the acetabular liner shows that edge loading has occurred.Taper analysis for the linear wear of the ball head measured the maximum depth of material loss measured at 56.1 ¿m.Compared to former cases, the findings regarding the wear on the bearing surface is higher than expected.A production documentation of all four implants, including the material certificates, did not show any deviation.The certificates demonstrate that the raw material is a wrought cobaltchromium-molybdenum alloy as specified in the product files.There are no indications that the parts failed to match specification at the time of manufacturing.A complaint history was conducted and it was shown that the reported failure mode is covered by the risk management file in severity and occurrence.The combination of the devices was approved by smith and nephew.The ball head and the liner are no longer available on the market.Abrasion of implant surfaces and development of osteolysis as a reaction to foreign bodies is a possible side effect from hip arthroplasty according to the ifu versions, lit no.12.23, ed.09/05 and lit no.12.07, ed.01/03.Based on the received information a medical assessment was conducted.It is stated that the inclination of the cup is pretty flat with about 24 degrees.According to the surgical technique (lit.No.01773-en, v6, 07/20), the acetabular component is to be impacted with 10-20 degrees anteversion and 40-50 degrees inclination.The provided medical information confirms the reported blood cobalt ion level of 214 nmol/l and chromium ion level of 214nmol/l.The reported loosening of the acetabular component can be seen as a result of metallosis but loosening and the migration of the cup from the reported fall could also accelerate wear, lead to metal debris, and result in metalosis.However, the confirmed edge loading cannot be ruled out as a contributing factor.Therefore, the relationship between the reported event and the devices can be confirmed.The devices in questions, ball head stem and liner, are no longer available on the market.A wear patch was observed on the metal-on-metal joint.The investigation performed demonstrate that the material of all implants is within specification and that the material characteristics did not cause the observed metal wear.The alignment of cup and ball head may have contributed to the formation of a wear patch on the metal-on-metal joint.The root cause is therefore attributed to a known inherent risk.The need for further actions is not indicated.Smith and nephew will monitor these devices for further similar issues.The returned devices will be retained.

• Brand Name: HI-LUBRIMET SHELL 7
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10645199
• MDR Text Key: 210354492
• Report Number: 1020279-2020-05208
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2012
• Device Catalogue Number: 75001023
• Device Lot Number: F0500013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75000986, METAL/ BALL HEAD, LOT: 047110; 75001072,HI-LUBRIMET METAL INSERT,LOT: 047095/19; 75002704,SL-PLUS STANDARD,LOT: 0412.13.6362
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 72