MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS PRI STD OFFSET 12/14 XSM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71928846
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the root cause of the revision was the unspecified infection based on the report of previous revision for infection, noted intraoperative frank infection and development of symptomatic septic right hip following the cessation of the ongoing suppression antibiotics 10 days prior.Without the supporting lab/pathology results and/or further documentation the source of infection cannot be confirmed, although the surgeon reportedly did not fault the implants.The patient impact beyond the reported symptomatic septic right hip revision tha and probable resumption of suppression antibiotics cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history on the listed part revealed no prior complaint for the listed batches 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.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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: CPCS PRI STD OFFSET 12/14 XSM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7688806
• Report Number: 1020279-2018-01297
• Device Sequence Number: 10963921
• Product Code: JDI
• UDI-Device Identifier: 03596010473400
• UDI-Public: 03596010473400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2018

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 Expiration Date: 08/09/2024
• Device Catalogue Number: 71928846
• Device Lot Number: 14HM07536
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/15/2018
• Supplement Report FDA Received Date: 09/08/2018
• 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
• Patient Age: 60 YR
• Patient Weight: 120