MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MOBILELINK ACETABULAR CUP SYSTEM; MOBILELINK SHELL, TILASTAN, TICAP-COATED CLUSTER HOLE, O.D. 44MM

Model Number	183-101/44
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
3 months after a patient underwent a surgical procedure, the acetabular cup got loose along with the screw.
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.
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
3 months after a patient underwent a surgical procedure, the acetabular cup got loose along with the screw.
Event or Problem Description
3 months after a patient underwent a surgical procedure, the acetabular cup got loose along with the screw.
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.Based on the given bony situation of the traumatically changed acetabulum, the acetabulum itself overall was less suitable for anchoring a cementless press-fit cup thus leading to loosening after a relatively short period of time.A material or a product failure is not assumed in this case.

• Brand Name: MOBILELINK ACETABULAR CUP SYSTEM
• Common Device Name: MOBILELINK SHELL, TILASTAN, TICAP-COATED CLUSTER HOLE, O.D. 44MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: sagar shetty ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 13469090
• Report Number: 3004371426-2022-00001
• Device Sequence Number: 5232877
• Product Code: LPH
• UDI-Device Identifier: 04026575175468
• UDI-Public: 04026575175468
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K182321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 09/30/2024
• Device Model Number: 183-101/44
• Device Catalogue Number: 183-101/44
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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 Sex: Female