MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS; R3 0 DEG XLPE ACET LNR 36MM X MM56

Model Number 71332756

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2017

Event Type  Injury  

Event Description

It was reported a revision surgery due to suspected infection and instability.

Manufacturer Narrative

(b)(4).

Event Description

Per surgeon's note, the infection was confirmed.Surgeon did 3 washouts and after that per standard procedure decided to change head and liner.

• Brand Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Type of Device: R3 0 DEG XLPE ACET LNR 36MM X MM56
• 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 5001 ; SZ 5001
• MDR Report Key: 6539750
• MDR Text Key: 74261491
• Report Number: 1020279-2017-00312
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598004
• UDI-Public: 03596010598004
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 71332756
• Device Catalogue Number: 71332756
• Device Lot Number: 16MM11791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PART: 71303600, LOT:16MM14884, COCR 12/14 FH
• Patient Outcome(s): Hospitalization; Required Intervention