MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL

Model Number	71354703
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to infection.Hip prepped and draped joint opened.Specimens taken joint lavaged and debrided intensely w hydrogens peroxide.Acetabulum exposed and reamed.Cup trialed.Cemented cup applied.The femoral canal reamed.Redapt stem trialed w reduction.The stable joint capsule and leg length achieved definitive implants inserted.Hip reduced.Hip closed.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to infection.The affected devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Smith and nephew has been unable to obtain device details.As device information was not made available, device history record, complaint history and sterilization documentation review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: HIP IMPLANT
• Common Device Name: PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9284152
• Report Number: 1020279-2019-03911
• Device Sequence Number: 2500368
• Product Code: JDH
• UDI-Device Identifier: 00885556579282
• UDI-Public: 00885556579282
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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 Model Number: 71354703
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1