MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LCU - HIP SYSTEM; LCU HIP STEMS, CEMENTLESS, STANDARD TYPE, TI6AL4V, HX COATING, TAPER 12/14

Model Number	165-018/26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2023 the link sales representative was informed.He only sent the complaint by post to the returned goods department.We received the information about the receipt of complaint samples (instruments) via the returned goods department.The date of receipt in the returned goods was (b)(6) 2023.This information was not directly recognised as a new complaint.This delayed the assessment as a reportable incident, which took place on (b)(6) 2023.The sales representative was sensitised accordingly.
Event or Problem Description
Hip stem could not be placed into final position.
Additional Manufacturer Narrative
On 23 may 2023 the link sales representative was informed.He only sent the complaint by post to the returned goods department.We received the information about the receipt of complaint samples (instruments) via the returned goods department.The date of receipt in the returned goods was 16 june 2023.This information was not directly recognised as a new complaint.This delayed the assessment as a reportable incident, which took place on (b)(6) 2023.The sales representative was sensitised accordingly.The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
Hip stem could not be placed into final position.

• Brand Name: LCU - HIP SYSTEM
• Common Device Name: LCU HIP STEMS, CEMENTLESS, STANDARD TYPE, TI6AL4V, HX COATING, TAPER 12/14
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17266570
• Report Number: 3004371426-2023-00053
• Device Sequence Number: 5960567
• Product Code: LZO
• UDI-Device Identifier: 04026575415342
• UDI-Public: 04026575415342
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K213770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 165-018/26
• Device Catalogue Number: 165-018/26
• Device Lot Number: 2306081
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2023
• 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
• Patient Sex: Unknown