MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71365705

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

Event occured during a revision surgery which was reported under 1020279-2017-00428.

Event Description

It was reported that during stem implantation the threaded tip of the insertion instrument broke off in a stem.The piece was not recovered and is in the threaded shoulder of the stem which was implanted.

Manufacturer Narrative

A correction based on new information received.

Manufacturer Narrative

Please see attached file for the results of our investigation.(b)(4).

• Brand Name: ANTHOLOGY INSERTER POSTER HARD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 6642999
• MDR Text Key: 77628924
• Report Number: 1020279-2017-00429
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010555663
• UDI-Public: 03596010555663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2017

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
• Device Operator: Health Professional
• Device Model Number: 71365705
• Device Catalogue Number: 71365705
• Device Lot Number: 14BM11937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 06/23/2017; 06/23/2017
• Supplement Dates FDA Received: 07/20/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 109