MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 36 0 DEG 62-64 SZ H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333397
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to poly wear.Liner and head were removed.Primary surgery was performed on 2003.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to poly wear.Liner and head were removed.The affected cobalt chrome femoral head and reflection xlpe liner 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.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 or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.Potential causes could include but not limited to friction, joint tightness or osteolysis but no actual root cause can be determined at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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: REF XLPE 36 0 DEG 62-64 SZ H
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8967582
• Report Number: 1020279-2019-03287
• Device Sequence Number: 2099517
• Product Code: LPH
• UDI-Device Identifier: 03596010479747
• UDI-Public: 03596010479747
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71333397
• Device Lot Number: 12FM05911
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention