MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 32MM ID INTL DLT CER LNR 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number 71331748

Device Problems Out-Of-Box Failure (2311); Scratched Material (3020)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2017

Event Type  Injury  

Event Description

During a hip arthroplasty surgery, when opened the package of liner, the surgeon found obvious scratches on the surface of the liner.The surgeon questioned the liner quality, and insisted to change another one.The distributor had to go back and fetched a brand new liner, which lead to the surgery time was delayed for 60min.

• Brand Name: R3 32MM ID INTL DLT CER LNR 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• 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: robert rust ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6563229
• MDR Text Key: 75031036
• Report Number: 1020279-2017-00339
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331748
• Device Lot Number: 16GT73679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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
• Patient Age: 51 YR
• Patient Weight: 48