MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER

Model Number 71331856

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

It was reported that, during surgery, the outer cup could not be implanted.Another cup of the same size, from smith and nephew, was used to complete the procedure.It is unknown if surgery was delayed.No injury has been reported.

Manufacturer Narrative

Results of investigation: it was reported that during surgery, the cup couldn't be implanted.Another cup of the same size, from smith and nephew was used to complete the procedure.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Some potential causes of the reported event could include but not limited to procedural/user error, surgical technique used or size of device.

• Brand Name: R3 0 HOLE ACET SHELL 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10480668
• MDR Text Key: 207929689
• Report Number: 1020279-2020-04370
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597618
• UDI-Public: 03596010597618
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71331856
• Device Catalogue Number: 71331856
• Device Lot Number: 20BW04864
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CN: 71335756, LN: 18BM02108