MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0DEG 32MM TRIAL 50MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71365150

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 10/31/2017

Event Type  Injury  

Event Description

It was reported that during the surgery after shell implantation, the liner trial was settled but did not fit well.There was a 40 minutes delay of the surgery.

Manufacturer Narrative

The associated complaint device was returned for evaluation.A visual inspection of the trial 32 mm x 50 mm indicated damage to the profile and inner features.This returned device was manufactured 2012.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional analysis indicated that the trial showed visible signs of wear but was found to be within the specified print tolerance.It was checked for function with a shell and functioned as intended.This dimensional and functional evaluation could not confirm or explain the stated complaint.A clinical analysis concluded that it was reported that there was a 40 minute extension of surgery time due to a device/fit related issue.The complaint reports that the procedure was completed with a backup device, and there is no injury to the patient.Therefore no further clinical assessment is warranted.Based on this investigation, the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 0DEG 32MM TRIAL 50MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN
• MDR Report Key: 7028724
• MDR Text Key: 91933418
• Report Number: 1020279-2017-01026
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71365150
• Device Lot Number: 12LDS0026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization