MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number	71333334
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.Mechanical fall secondary to etoh (alcohol), fell on right side, causing periprosthetic fracture.Afterwards, replacement of shell and liner was performed due to recurrent dislocations.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the surgeon¿s statement provided, the root cause of the peri- prosthetic fracture was due to the patient¿s intoxication, trip and fall on her right side.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of manufacturing records did not reveal any abnormalities that could have contributed to the reported issue.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: REF XLPE 32 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8068718
• Report Number: 1020279-2018-02471
• Device Sequence Number: 14023278
• Product Code: LPH
• UDI-Device Identifier: 03596010455673
• UDI-Public: 03596010455673
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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 Expiration Date: 11/15/2021
• Device Catalogue Number: 71333334
• Device Lot Number: 11LM10979
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 02/21/2019
• 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