MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CEMENT ACET COM 28/49; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71352849

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a revision surgery was performed due to poly loosening.Device was explanted and replaced for a competitor one, also a s&n head implant was implanted.

Manufacturer Narrative

The associated 20 degree reflection all-poly cemented acetabular component was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including 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 part 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 or adverse event could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: REF CEMENT ACET COM 28/49
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8746856
• MDR Text Key: 149617783
• Report Number: 1020279-2019-02555
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03596010198235
• UDI-Public: 03596010198235
• Combination Product (y/n): N
• 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: 10/09/2019

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: 71352849
• Device Lot Number: 09ET73963
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/30/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention