MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 LINER CERAMIC B.DELTA; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL,

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Subluxation (4525)

Event Date 05/01/2011

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-2020-00030483-2.

Event Description

It was documented on the paper that the tr3¿ biolox delta ceramic acetabular system (smith & nephew) was applied to 175 patient, 1 one these patients underwent a revision surgery due to subluxation.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, the data presented in the literature review article refers to a patient that required a revision tha due to a subluxation within 45 days of the primary tha.Responses to the requested clinical documentation had not been received as of the date of this investigation; therefore, the root cause and the patient impact beyond that which is documented in the article could not be confirmed.No further medical assessment is warranted at this time.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN R3 LINER CERAMIC B.DELTA
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11002006
• MDR Text Key: 221224189
• Report Number: 1020279-2020-07403
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention