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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Apnea (1720); Low Blood Pressure/ Hypotension (1914); Pulmonary Dysfunction (2019); Renal Failure (2041); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	10/29/2014
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8565623
• Report Number: 1020279-2019-01712
• Device Sequence Number: 19335609
• Product Code: MBL
• UDI-Device Identifier: 03596010598011
• UDI-Public: 03596010598011
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 71332758
• Device Lot Number: 14KM05553
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Death; Hospitalization