MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 36 20 DEG 58-60 G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333346
Health Effect - Clinical Codes	Swelling (2091); Injury (2348)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision thr with an exchange of the femoral head and acetabular liner.The patient complained of pain and mri testing showed a fluid pocket around the proximal femur.No visible signs of damage were observed in surrounding tissues, acetabular component, nor stem trunnion.
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).

• Brand Name: REF XLPE 36 20 DEG 58-60 G
• 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: 6873115
• Report Number: 1020279-2017-00753
• Device Sequence Number: 750245
• Product Code: LPH
• UDI-Device Identifier: 03596010479761
• UDI-Public: 03596010479761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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 Expiration Date: 02/15/2019
• Device Catalogue Number: 71333346
• Device Lot Number: 09BM12594
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 01/29/2018
• 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: PART# 71306112 LOT# 09CM11886; PART# 71336458 LOT# 08MM13076; PART# 71336530 LOT# UNKNOWN; PART# 71343603 LOT# 09BM01004
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention