MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335752

Device Problems Failure To Adhere Or Bond (1031); Difficult or Delayed Positioning (1157); Device-Device Incompatibility (2919)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Regurgitation (2259); Blood Loss (2597)

Event Date 05/01/2017

Event Type  Injury  

Event Description

It was reported that during bilateral total hip arthroplasty the surgeon experienced difficulty locking the acetabular insert effectively, to which the surgeon decided to use the back-up liner to complete the procedure thus leading to surgical delay.During surgical delay it was reported that the patient's blood pressure became unstable, bleeding volume increased and patient experienced regurgitation, all leading to postponement of contralateral hip arthroplasty to another day.

Manufacturer Narrative

(b)(4).

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6593709
• MDR Text Key: 76039380
• Report Number: 1020279-2017-00371
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598332
• UDI-Public: 03596010598332
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Catalogue Number: 71335752
• Device Lot Number: 13DM06450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR
• Patient Weight: 51