MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71343600

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/21/2010

Event Type  Injury  

Event Description

It was reported that the patient was re admitted on the hospital due to pain, he was treated with medication.

Manufacturer Narrative

Additional information: d4 and h4.It was reported that the patient was re-admitted to the hospital due to pain.The affected synergy porous stem, r3 acetabular insert, r3 no hole coated shell, oxinium femoral head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.It was communicated that this adverse event has been resolved with medications.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to traumatic injury, joint tightness, material in use or patient reaction.It was communicated that this adverse event has been resolved with medications.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 36 MM +0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9530967
• MDR Text Key: 173065263
• Report Number: 1020279-2019-04639
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010477279
• UDI-Public: 03596010477279
• Combination Product (y/n): N
• PMA/PMN Number: K022958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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: Lay User/Patient
• Device Expiration Date: 10/08/2020
• Device Model Number: 71343600
• Device Catalogue Number: 71343600
• Device Lot Number: 10KM07239
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Weight: 77