MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LUBINUS SPII HIP PROSTHESIS SYSTEM; LUBINUS SPII HIP STEM

Model Number 127-760/17

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Type  malfunction  

Event Description

Stem fracture occurred 3.5 years after the implantation.The patient described pain in the buttocks after jumping off a truck.

Manufacturer Narrative

The clearly visible lysis seam on the x-ray images between the proximal stem area and the corresponding cement coat (implant-cement interface) allows oscillation of the proximal stem, which may lead to a fatigue fracture.We assume that the bony support was insufficient around the prosthesis, due to resorption processes.The visual inspection shows an intensely polished medial and dorsal surface of the proximal fractional part.This evidence confirms the assumption of the oscillated proximal stem.Further laboratory investigations show that the fatigue break (approx.80%) started at the highest bending stress die - the lateral side.In this area the typically swing stripes could be detected.The remaining 20% are caused by force fracture.No stem-surface damage is visible nearby though.Overweight may also cause a relative contraindication listed in our surgical technique.Probably the relatively high activity level of the patient (electrician) contributed to the breakage.The jumping off a truck surely facilitated the adverse event.This event occurred outside of the u.S.And involves a product that was manufactured outside of the u.S.However, because the affected product is also marketed in the u.S., waldemar link (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.(b)(4).

• Brand Name: LUBINUS SPII HIP PROSTHESIS SYSTEM
• Type of Device: LUBINUS SPII HIP STEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; hamburg 2233 9; GM 22339
• Manufacturer Contact: philipp kottmann ; barkhausenweg 10; hamburg 22339 ; GM 22339 ; 053575432
• MDR Report Key: 4273274
• MDR Text Key: 5231480
• Report Number: 3004371426-2014-00006
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K953653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2014
• Device Model Number: 127-760/17
• Device Catalogue Number: 127-760/17
• Other Device ID Number: GMDN: 34190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CERAMIC PROSTHESIS HEAD: 36MM RP0000000; ACETABULUM CUP: MODEL #180-966/56, SN: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 102