MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122546

Device Problems Pitted (1460); Appropriate Term/Code Not Available (3191)

Patient Problems Toxicity (2333); Test Result (2695)

Event Date 09/17/2018

Event Type  Injury  

Event Description

It was reported that a right hip revision surgery was performed due to metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and sleeve were removed.The cup and stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the hemi head, cup, stem and sleeve 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 cup and stem.Similar complaints have been identified for the hemi head and sleeve and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu and surgical technique 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.No further actions are required at this time.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s previous fall had on his pain and clinical status.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the implantation operative report indicated the acetabular component was implanted at approximately 25° anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the metal debris.The reported pain, elevated metal ions and joint effusion noted on mri along with intraoperative findings of mild metallosis within the capsular tissue as well as significant wear on the trunnion may be consistent with findings associated with metallosis and trunnionosis.However, the root cause of the metallosis and pseudotumor cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information, the proposed root cause is improper loading due to malpositioning of the implant during implantation.If the products or 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.

• Brand Name: HEMI HEAD 46MM
• 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: 9185880
• MDR Text Key: 162363342
• Report Number: 3005975929-2019-00365
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071588
• UDI-Public: 00885556071588
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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: Other
• Device Expiration Date: 04/29/2013
• Device Model Number: 74122546
• Device Catalogue Number: 74122546
• Device Lot Number: 08DW16552
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 52MM W/ IMPTR 74120152/089098; ANTHOLOGY HO POR PL HA SZ 7 71357107/08EM20397A; MODULAR SLEEVE PLUS 0MM 12/14 74222200/08AW15336
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR