MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 16; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71309016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had radiation of pelvic area causing necrosis of opposite hip (left) which caused shortening.Surgeon tried equalizing the two leg lengths which caused subsidence.Cemented stem was used for revision due to poor bone quality.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the x-ray provided is a single view so comparisons cannot be made to original placement and which component subsided but there could be movement of both the cup and the stem.The root cause of the subsidence is most likely due to the prostate cancer and radiation treatment which was possibly a contributor to the poor bone quality and reported necrosis.The patient impact beyond shortening of the left hip and revision procedure cannot be concluded.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

• Brand Name: SYN POR PLUS HA SO STEM SZ 16
• Common Device Name: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8582801
• Report Number: 1020279-2019-01775
• Device Sequence Number: 13957370
• Product Code: MEH
• UDI-Device Identifier: 03596010459718
• UDI-Public: 03596010459718
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K002996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 71309016
• Device Lot Number: 17GM06167
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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