MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 9; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71309109
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to: there is bone loss around proximal stem and cup due to some type of acetabular loosening, pain radiating into hip and groin as main symptoms.Surgeon opened the joint via previous incision, inspected stem and cup and removed head.Stem was well fixed.Liner was removed using appropriate tool.Screws removed via articulating screwdriver.Cup was removed via zimmer explant.Surgeon reamed to 55mm and inserted a 51mm polar cup cemented.An appropriate 28mm plus zero head trialed and hip was stable.Liner and head were inserted as per technique.Surgeon felt hip was stable.A zimmer grip plate was also used.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it was reported that a revision tha was performed on a 64yr old female due hip and groin pain secondary to bone loss around proximal stem and cup resulting from ¿some type of acetabular loosening¿.However, no clinically relevant supporting documentation was provided, therefore, a thorough medical investigation could not be performed.The patient impact beyond the reported pain, revision procedure and an expected brief post-operative convalescence phase cannot be concluded.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: SYN POR PLUS HA HO STEM SZ 9
• 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: 8307683
• Report Number: 1020279-2019-00461
• Device Sequence Number: 62756
• Product Code: MEH
• UDI-Device Identifier: 03596010459749
• UDI-Public: 03596010459749
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002996
• 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): 06/11/2019

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: 71309109
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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