MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RALLY HV AB BONE CEMENT 40 GRAMS; BONE CEMENT, ANTIBIOTIC

Model Number	71271570
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during implantation the rally hv ab bone cement 40 grams was outdated and used in the patient.No injury was reported as a consequence of this problem.
Additional Manufacturer Narrative
After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that, during a tha surgery, the rally hv ab bone cement 40 grams was outdated and used in the patient.No injury was reported as a consequence of this problem.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable nor to be a valid product complaint for s+n, since the legal manufacturer of the device involved (rally hv ab bone cement 40 grams) is tecres and not s+n.A complaint notification was sent to the legal manufacturer concerning this complaint requesting.

• Brand Name: RALLY HV AB BONE CEMENT 40 GRAMS
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12294343
• Report Number: 1020279-2021-06228
• Device Sequence Number: 14373219
• Product Code: MBB
• UDI-Device Identifier: 00885556582220
• UDI-Public: 00885556582220
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 71271570
• Device Catalogue Number: 71271570
• Device Lot Number: 16ETC0031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: Required Intervention