MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ECHELON REV STEM UNCEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKN01100805

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

Patient Problem Nerve Damage (1979)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case.Rayan, f., konan, s., & haddad, f.S.(2010).Uncemented revision hip arthroplasty periprosthetic femoral fractures-a prospective analysis.Hip international, 20(1), 38-42.Doi: 10.1177/112070001002000106.

Event Description

On the literature article named "uncemented revision hip arthroplasty in b2 and b3 periprosthetic femoral fractures - a prospective analysis", it was reported that, after an echelon rev stem uncem system and accord cable system had been implanted on 1 patient, the patient experienced a partial sciatic nerve palsy.This was treated expectantly and complete recovery was noted on 12 weeks.The specific treatment followed to treat this adverse event is unknown.Stems from five companies, including s+n, were analyzed on the paper.Also cables from two different companies, including s+n, were analyzed on the paper.It cannot be ruled out that s+n products were present at the moment of the adverse event.Additional information is unknown.The patient outcome is unknown.

Manufacturer Narrative

Results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, the article reported that one patient experienced a partial sciatic nerve palsy which was ¿treated expectantly and complete recovery was noted on 12 weeks¿.The specific treatment to treat this adverse event is unknown.The involvement of s+n components could not be confirmed (since 5 companies including s+n were analyzed on the paper).Although it cannot be ruled out that s+n products were involved in the reported events, the s+n hip systems ifu does address nerve palsy.Patient specific clinically relevant documentation had not been provided as of the date of this medical investigation.The clinical root cause of the reported sciatic nerve palsy and/or the patient outcome beyond that which was documented in the article could not be confirmed nor concluded.Therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN ECHELON REV STEM UNCEM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12602272
• MDR Text Key: 276583508
• Report Number: 1020279-2021-07488
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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 Catalogue Number: UNKN01100805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/09/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other