MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MOBILELINK ACETABULAR CUP SYSTEM; TICAP SHELL, CLUSTER HOLE

Model Number	183-101/50
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hemi pelvis fracture.
Additional Manufacturer Narrative
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
Hemi pelvis fracture.

• Brand Name: MOBILELINK ACETABULAR CUP SYSTEM
• Common Device Name: TICAP SHELL, CLUSTER HOLE
• 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: 17030019
• Report Number: 3004371426-2023-00047
• Device Sequence Number: 12391142
• Product Code: LPH
• UDI-Device Identifier: 04026575175499
• UDI-Public: 04026575175499
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 05/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 183-101/50
• Device Catalogue Number: 183-101/50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: 64 YR
• Patient Sex: Unknown