MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR; MP RECONSTRUCTION PROSTHESIS SYSTEM S-1, TI6AL4V MICROPOROUS, CEMENTLESS, L 180,

Model Number 172-918/14

Device Problems Failure to Osseointegrate (1863); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Scratched Material (3020); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.

Event Description

On january 17th, 2019, (b)(4) customer service was informed that an mp proximal body malfunctioned during a revision surgery that had intended to address a patient's dislocation.The surgeon had attempted to remove the proximal body off the stem and the whole thing came off.Due to the malfunction, the surgical technique had to be altered.The original case took place at (b)(6) clinic with dr.(b)(6).The malfunctioned parts will be shipped back to (b)(4).The operative report from the original revision surgery was sent to the (b)(4) complaints department.Note (b)(6) 2019, (b)(6): on (b)(6) 2019, (b)(6) called sales representative (b)(4) to get more additional details for the complaint.It was found that the link mp stem, link proximal body and link screw was used with a competitive constraint liner.The sales representative confirmed that the screw was removed by the surgeon before attempting to remove the proximal body from the stem.For unknown reason the proximal body was not disassociating with the stem.Upon putting more effort, the stem and the proximal body came off.

Event Description

On (b)(6) 2019, linkbio customer service was informed that an mp proximal body malfunctioned during a revision surgery that had intended to address a patient's dislocation.The surgeon had attempted to remove the proximal body off the stem and the whole thing came off.Due to the malfunction, the surgical technique had to be altered.The original case took place at mayo clinic with dr.S.The malfunctioned parts will be shipped back to linkbio.The operative report from the original revision surgery was sent to the linkbio complaints department.Note 20190121 nm: on january 21st, 2019, nm called sales representative s.P.To get more additional details for the complaint.It was found that the link mp stem, link proximal body and link screw was used with a competitive constraint liner.The sales representative confirmed that the screw was removed by the surgeon before attempting to remove the proximal body from the stem.For unknown reason the proximal body was not disassociating with the stem.Upon putting more effort, the stem and the proximal body came off.Update 15 april 2019: "the head was on the mp stem.The head is what dislocated from the constrained liner.It was a failure of the constrained liner that caused the dislocation.We knocked the head off the stem before trying to remove the proximal body".Sales rep.

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The visual inspection confirms that the neck segment cannot be disassembled from the prosthesis stem.The stem shows no signs of osseointegration.Several scratches are visible at the surface.One deep notch is visible at the taper.The notch is caused by impingement between the neck segment and the cup/liner of a competitive manufacturer.The neck segment and prosthesis stem could not be disassociated because these were weld together by unintended movement over a period of time.This movement can only occur due to a loosened screw.The screw was not available for investigation.It cannot be clarified if impingement may have contributed to this error.According to the information received a failure of the constrained liner from competitive manufacturer caused the dislocation of the head.These samples and x-ray images are not available for investigation.The instruction for use strictly recommends not combining implants of different manufacturer.Thereby the complaint is not justified.Surgical technique - important information (extract): 2.Correct handling of the implant is very important.Our implants must not be combined with implants from other manufacturers.

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The visual inspection confirms that the neck segment cannot be disassembled from the prosthesis stem.The stem shows no signs of osseointegration.Several scratches are visible at the surface.One deep notch is visible at the taper.The notch is caused by impingement between the neck segment and the cup/liner of a competitive manufacturer.Trunnionosis (wear between taper/ head) is assumed to be the outcome.The neck segment and prosthesis stem could not be disassociated because these were weld together by unintended movement over a period of time.This movement can only occur due to a loosened screw.The screw was not available for investigation.It cannot be clarified if impingement may have contributed to this error.Dislocation of the implants is the final result of this chain of errors.The samples of the competitive manufacturer and x-ray images are not available for investigation.The instruction for use strictly recommends not combining implants of different manufacturer.Thereby the complaint is not justified.Surgical technique - important information (extract): 2.Correct handling of the implant is very important.Our implants must not be combined with implants from other manufacturers.

Event Description

On (b)(6) 2019, linkbio customer service was informed that an mp proximal body malfunctioned during a revision surgery that had intended to address a patient's dislocation.The surgeon had attempted to remove the proximal body off the stem and the whole thing came off.Due to the malfunction, the surgical technique had to be altered.The original case took place at mayo clinic with dr.Sierra.The malfunctioned parts will be shipped back to linkbio.The operative report from the original revision surgery was sent to the linkbio complaints department.Note 20190121 nm: on (b)(6) 2019, nm called sales representative (b)(6) to get more additional details for the complaint.It was found that the link mp stem, link proximal body and link screw was used with a competitive constraint liner.The sales representative confirmed that the screw was removed by the surgeon before attempting to remove the proximal body from the stem.For unknown reason the proximal body was not disassociating with the stem.Upon putting more effort, the stem and the proximal body came off.

• Brand Name: PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
• Type of Device: MP RECONSTRUCTION PROSTHESIS SYSTEM S-1, TI6AL4V MICROPOROUS, CEMENTLESS, L 180,
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8342930
• MDR Text Key: 136250463
• Report Number: 3004371426-2019-00112
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K142187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2015
• Device Model Number: 172-918/14
• Device Catalogue Number: 172-918/14
• Device Lot Number: 0950034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 01/17/2019; 01/17/2019
• Supplement Dates FDA Received: 04/01/2019; 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 56