MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT PF STEM-240MM SZ 18; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 71354318

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

Patient Problem Anemia (1706)

Event Date 08/07/2014

Event Type  Injury  

Event Description

It was reported that, after thr surgery had been performed with a redapt modular stem, the clinical subject experienced acute anemia and had to be hospitalized.This adverse event was treated with medication and it was resolved.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the clinical subject experienced acute anemia post redapt modular stem thr with a hct drop to 6.7 post-operatively, and although hemodynamically stable, had to be hospitalized.Documentation reflects the patient was discharged to rehab/snf (b)(6) 2014 in a wheelchair with wbat.The onset of the serious, anticipated adverse event (ae#1) was noted as (b)(6) 2014 and reportedly resolved with medication therapy the next day on (b)(6) 2014.Based on the information provided, the patient had significant comorbidities including ckd, dm, and vit b12 deficiency among others; however, the surgical procedure and/or device could not be ruled out as possible contributing factors.No blood products transfused intraoperatively or prior to discharge per crf #050/redapt #037.The subject cross load data indicated the subject #10008 treatments start/surgery date was the 2nd visit (01/30/2017) with date off-study/completion 11/25/2019.The root cause of the reported event could not be definitively concluded and the patient impact beyond the reported medication and hospitalization could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to surgical complication or patient medical history.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: REDAPT PF STEM-240MM SZ 18
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11849439
• MDR Text Key: 251434302
• Report Number: 1020279-2021-04453
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556210697
• UDI-Public: 885556210697
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71354318
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention