MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Toxicity (2333); Injury (2348)

Event Date 12/20/2016

Event Type  Injury  

Event Description

Patient had high metal ion levels.During the revision the surgeon reportedly found taper corrosion.

Manufacturer Narrative

Through a legal claim, additional information was received for an existing complaint reporting that the patient had high metal ion levels and had undergone revision surgery.During the right hip revision surgeon found taper corrosion.At the time of revision, the bhr cup, hemi head and modular sleeve were revised, and the original femoral stem remained implanted.As of today, additional information has been requested for this complaint but has not become available.An acetabular cup (74120156, 10bw25726 028), hemi head and modular sleeve were previously received for investigation following revision.The returned hemi head and sleeve's part and lot numbers were obscured due to engagement.Based on the limited device detail previously provided, the part and lot details of the hemi head, modular sleeve and femoral stem were tentatively identified using production systems (subject to confirmation in medical records) as follows: 74222200 10aw25484 modular sleeve.74122550, 08mw20696 hemi head 50mm.71356106, 10gm05568 anthology femoral stem size 6.As of today, chart stickers or further medical records have not yet been supplied to further confirm these device details.Review of manufacturing records for these devices (believed to be involved in this event) did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.In our previous investigation, a retrieval analysis was conducted on the returned hemi head, modular sleeve & bhr cup.The bearing surface of the hemi-head showed a scratch.The rim of the cup showed scratches.Time in vivo is needed to compare the measured combined linear wear for this device with the historical wear date 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 device whilst the maximum linear wear for the head was 10.1 m.Material loss was measured on the internal taper of the sleeve, with the deepest material loss of 91.4 m.The supplied medical information was reviewed.According to the provided revision report, there was metallosis with synovitis and retro-acetabular bone loss.The taper was deemed to have changed consistent with trunnionosis.No information about the reported blood metal ions were provided.No information was provided that could explain or have contributed the reported findings.A root cause cannot be identified.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.

Manufacturer Narrative

This complaint was reopened due to receipt of additional medical records.Previously, a 50mm hemi head (details not visually confirmed - part 74122550, batch 08mw20696), modular sleeve (details not visually confirmed - part 74222200, batch 10aw25484) and bhr cup (part 74120156, batch 10bw25726, sn (b)(6)) were received for investigation, the anthology stem remained implanted.The implanted devices, were all used in treatment.A review of the complaint history for the head, cup, sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head and cup.Similar complaints have been identified for the sleeve and stem and this 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 analysis identified a scratch on the bearing surface of the hemi head.Scratches were observed on the rim of the bhr cup.Maximum linear wear for the hemi head was 10.1¿m.Wear on the cup was low and within the manufacturing aberrations of the device.Taper analysis showed mild discoloration on the internal sleeve taper with a maximum depth of material loss measured to be 91.4 ¿m.Based on historic wear data, after six years in vivo, the measured linear wear of the head is in line with the expected wear for a non-edge loaded smith and nephew large diameter metal-onmetal device.The available medical documents were reviewed.Although it was reported that the metal ion were elevated, no levels were provided.The taper was deemed to have changed consistent with trunnionosis.The product analysis noted the bearing surface of the hemi-head and the rim of the cup showed scratches.The material loss noted on the internal taper of the sleeve, was consistent with the intraoperative findings.Although the reported clinical reactions are consistent with findings associated with metal debris, the root cause of the reported clinical reactions cannot be confirmed but trunnionosis is the likely source.It also cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implants.One thing we noted was that in the report it states that the taper has fairly high wear and this lines up with what the surgeon was reporting in the revision surgery.Based on the available information and explant analysis, a potential root cause for the device failure is improper loading possibly caused by mal-alignment of the implanted devices.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 have been retained at aurora.

• Brand Name: BHR ACETLR CUP HAP 56MM 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 6221031
• MDR Text Key: 63801184
• Report Number: 3005975929-2017-00005
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 10BW25726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356106/ANTHOLOGY HO POROUS SZ 6/10GM05568.; 74122550/HEMI HEAD 50MM/08MW20696.; 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14/10AW2548.; BHR 50MM MODULAR HEAD, PART AND LOT NUMBER UNKNOWN.; BHR 50MM MODULAR HEAD, PART AND LOT NUMBER UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 100