MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIAM.24MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	EBO101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation as it was discarded and is not available for return.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that there was a shoulder replacement.The patient reported oozing of the wound post-procedure.An exploration surgery and culture revealed the presence of an infection.The first stage of the revision was completed with a wash out.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that there was a shoulder replacement.The patient reported oozing of the wound post-procedure.An exploration surgery and culture revealed the presence of an infection.The first stage of the revision was completed with a wash out.

• Brand Name: CEMENT RESTRICTOR DIAM.24MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15815276
• Report Number: 3000931034-2022-00370
• Device Sequence Number: 5838102
• Product Code: JDI
• UDI-Device Identifier: 03700386922053
• UDI-Public: 03700386922053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K973453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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
• Device Model Number: EBO101
• Device Catalogue Number: EBO101
• Device Lot Number: 4652AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male