MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28ID 20 DEG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742854
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.The liner and the head were replaced.Primary surgery was performed on (b)(6) 2003.
Additional Manufacturer Narrative
The associated oxinium femoral head and reflection acetabular liner were not returned for evaluation.A clinical evaluation noted that no clinical supporting documentation to confirm the reported poly wear was provided.Per the report, ¿the surgeon does not blame the product.¿ the patient¿s unlabeled x-ray was provided and reviewed.However, the x-ray does not contribute to the investigation.Without the clinical information, labs, x-rays or explant a thorough investigation cannot be rendered.Should additional relevant information be provided this complaint will be re-evaluated.Our investigation including a review of the manufacturing records for the listed femoral head with the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.After repeated requests, smith and nephew has been unable to obtain device details for the liner of this complaint.Therefore, a review of device history record and complaint history cannot be completed.Without the return of the actual product involved, our investigation of this report is inconclusive.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 device or additional information be received, this complaint will be reevaluated.We consider this investigation closed.

• Brand Name: REF LNR 28ID 20 DEG SZ F
• 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: 8238614
• Report Number: 1020279-2019-00126
• Device Sequence Number: 2190252
• Product Code: LPH
• UDI-Device Identifier: 03596010232274
• UDI-Public: 03596010232274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 71742854
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71309012 / 03CM04483B71336256 / 03AM03644A; 71309012 / 03CM04483B71336256 / 03AM03644A
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention