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

Model 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 a poly wear.Poly and head were removed.
Additional Manufacturer Narrative
Additional information received by the customer has identified that this event has been already reported under 1020279-2019-03287.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

• 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: 9008450
• Report Number: 1020279-2019-03333
• Device Sequence Number: 11507430
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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 Expiration Date: 06/09/2022
• Device Model Number: 71333397
• Device Catalogue Number: 71333397
• Device Lot Number: 12FM05911
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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 NUMBER 71303203 / 16CM18533; PART NUMBER 71303203 / 16CM18533
• Outcome Attributed to Adverse Event: Hospitalization