MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF FXD NECK SIZE 2 HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352703
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2018 the patient was seen by his surgeon who noticed that he continued to have some occasional pain, as well as, a limp with weakness on his left side.Surgeon stated his limp will not change as he has permanent muscle damage.A repeat mri performed on (b)(6) 2018 revealed another fluid collection and his crp and esr were both elevated.A subsequent large aspiration was found to have increased white blood cells.It was determined he was suffering from an infection and would require a two-stage revision surgery.On (b)(6) 2018 patient underwent a left total hip arthroplasty resection and placement of an antibiotic spacer.Intraoperatively, it was clear that patient had severe infection throughout the hip.There was further necrosis and damage to the soft tissues.The entire pseudocapsule posteriorly was removed as there was abnormal tissue throughout.There was a very large area of infected tissue throughout the trochanter, his entire posterior aspect of his trochanter leaving only probably about 50% of the anterior abductor still connected.The rest of the posterior trochanter was bog.A picc line was inserted and 6 weeks of iv antibiotics was recommended.He was hospitalized for four days until his discharge on (b)(6) 2018, to a rehabilitation facility where he remained until (b)(6) 2018.On (b)(6) 2018 was re-admitted for stage-2 re-implantation of a new device.Following his discharge, the patient suffered repeated bleeding from his wound.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the clinical information provided, of the elevated metal ion levels, the necrotic tissue, and the trunnionosis, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The washout and debridement was likely left over necrotic tissue that needed to be removed.The second revision was as stated secondary to infection, a year after the first revision.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 parts revealed no prior complaints for the listed batches.Product was sterilized according to sterilization release documentation from quality control.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.

• Brand Name: SMF FXD NECK SIZE 2 HO
• 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: 8600797
• Report Number: 1020279-2019-01870
• Device Sequence Number: 11281362
• Product Code: LPH
• UDI-Device Identifier: 00885556159248
• UDI-Public: 00885556159248
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 06/15/2023
• Device Catalogue Number: 71352703
• Device Lot Number: 13FM11053
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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
• Patient Age: 71 YR