MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS GMBH R3 36MM ID US CRMC LINER 54; ACETABULAR LINER

Catalog Number 71338954

Device Problems Fracture (1260); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that the patient underwent a ct scan that showed the ceramic liner has fractured and has displaced deeper into the socket.No revision has been performed or scheduled to this date.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided and no relevant clinical information was received to assist in the evaluation.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

Event Description

Revision surgery was carried out due to suspected fracture of the ceramic liner.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Type of Device: ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS GMBH; gaensaecker 27; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS GMBH; gaensaecker 27; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5268698
• MDR Text Key: 32901081
• Report Number: 8010764-2015-00054
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Catalogue Number: 71338954
• Device Lot Number: 08GT22381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR