MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71332758

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

Patient Problems Apnea (1720); Low Blood Pressure/ Hypotension (1914); Pulmonary Dysfunction (2019); Renal Failure (2041); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 10/29/2014

Event Type  Injury  

Event Description

It was reported that the patient had left total hip arthroplasty.Postoperatively, he developed hypotension and shock.Afterwards, patient developed confusion and some encephalopathy.Patient's arterial blood gases showed respiratory acidosis, most likely acute-on-chronic.It is likely had significant untreated sleep apnea.He also had copd [chronic obstructive pulmonary disease].He also developed acute renal failure.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, based on the information provided, the cause of death in 2019 was listed as a gi bleed on the reported death certificate.Without the requested clinical documentation over the four years between the implantation and death there are many reasons this patient¿s demise.In addition, the patient¿s comorbidities could have led to a gi bleed or something else unrelated but none of them can be linked to the smith and nephew products or the technique during the implantation in 2014 (which were reported as not revised and remained implanted).No further clinical/medical investigation is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8565623
• MDR Text Key: 143576352
• Report Number: 1020279-2019-01712
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598011
• UDI-Public: 03596010598011
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332758
• Device Lot Number: 14KM05553
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART# 71303600, LOT 14JM01245; PART# 71332525, LOT 14EM07133; PART# 71335558, LOT 14JM03192; PART# 75100470, LOT A1311990; PART# 71303600, LOT 14JM01245; PART# 71332525, LOT 14EM07133; PART# 71335558, LOT 14JM03192; PART# 75100470, LOT A1311990
• Patient Outcome(s): Death; Hospitalization