MAUDE Adverse Event Report: SERF; PROSTHESIS, HIP, SEMI-CONSTRAINED

Catalog Number RM54202853

Device Problems Unsealed Device Packaging (1444); Incomplete or Missing Packaging (2312); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2018

Event Type  malfunction  

Event Description

During a hip surgery on (b)(6) 2018, an implant was to be used but found to be partially opened during the case.The implant was not used and sent to manufacturer to investigate.

• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): SERF; 85 avenue des bruyeres; decines cedex, 69153 ; FR 69153
• MDR Report Key: 7902705
• MDR Text Key: 121713980
• Report Number: 1226188-2018-00135
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: RM54202853
• Device Lot Number: 1610369A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2018
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1