MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS GMBH R3 32MM ID INTL DLT CER LNR 50MM; ACETABULAR LINER

Catalog Number 71331750

Device Problem Insufficient Information (3190)

Patient Problems Infiltration into Tissue (1931); Inflammation (1932); Discomfort (2330)

Event Date 07/01/2014

Event Type  Injury  

Event Description

It was reported that the patient presented with trochanteritis and infiltration.The patient was treated with unknown medications.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.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.

• Brand Name: R3 32MM ID INTL DLT CER LNR 50MM
• 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: 4919812
• MDR Text Key: 6008551
• Report Number: 8010764-2015-00028
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 71331750
• Device Lot Number: 10ET42511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2010
• 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: (B)(4)
• Patient Outcome(s): Other