MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71306612
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery.Original hip replacement was in 1999 by dr (b)(6).The patient had a revision of liner & head in (b)(6) 2018 due to dislocation & possible infection.Synergy size 12 stem removed & 64mm od multi hole cup & liner removed with a ceramic size 36 head.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, this is a complaint from australia reporting the revision of a hip that was originally implanted in (b)(6) 1999.Reportedly, the revision was due to ¿dislocation and infection¿.The revision was performed in 2 stages and completed after 2 wash-outs were performed between the two stages of the revision.Pictures of the components and a picture of the ¿washouts¿ brief reports were submitted for review.These did not aid in this investigation.No other medical information was provided.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the available information, the root cause for the ¿infection and dislocation¿ cannot be concluded.However an infection 18 years post implantation was likely hematogenous in origin and not a prosthesis failure.No information on the patient¿s current status was provided.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Product was sterilized according to sterilization release documentation from quality control.No further clinical/medical investigation is warranted at the time.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: SYN POR FEM COMP SZ 12
• 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: 7776802
• Report Number: 1020279-2018-01518
• Device Sequence Number: 16493675
• Product Code: LPH
• UDI-Device Identifier: 03596010194466
• UDI-Public: 03596010194466
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

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 Catalogue Number: 71306612
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 11/18/2018
• 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