MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL; IMPLANT

Catalog Number UNK_JR

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544)

Event Date 05/29/2014

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patients friend called and stated that the patient had a left hip replacement on (b)(6) 2014.She stated that patient was in pain since day one postop.Patient experienced pain, limited range of motion, would hear noises periodically and can't walk well.Patient had a revision on (b)(6) 2014.

Event Description

Patients friend called and stated that the patient had a left hip replacement on may 29, 2014.She stated that patient was in pain since day one postop.Patient experienced pain, limited range of motion, would hear noises periodically and can't walk well.Patient had a revision on (b)(6), 2014.** update (b)(6) 2018 : based on the attached medical review and operative reports, it appears that this pi addresses the removal of trauma devices for a left hip fracture.It is mentioned that t approx.6 months ago [from the time of the event date], the patient "began developing signs and symptoms of activity-related stress fracture.Subsequent imaging confirmed the presence of an intertrochanteric stress fracture plus some moderate osteoarthritis." patient had a revision of the trauma devices on (b)(6) 2014.

Manufacturer Narrative

Corrections to b5 (executive summary), d1 (product long description), g1/g2, the reported event of nail removal due to patient factors was confirmed by a hcp.Product deficiency was neither reported nor visible on provided x-rays according to available information a gamma3 nail was removed after an implantation period of approx.4 months with healed bone but progression of hip osteoarthritis.General aspects: the gamma nail is a temporary implant.Loads on the device produced by load bearing and the patient's activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.According to medical assessment nail removal became necessary due to progression of hip osteoarthritis which is considered patient related.Review of capa databases and risk analysis did not identify any conspicuity.There were no actions in place related to the reported event for the subject product.No non-conformity was identified.With available information the event was not linked to a deficiency of the device.In case the item and / or relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.

• Brand Name: UNKNOWN GAMMA NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel NJ D-242 32
• MDR Report Key: 7414145
• MDR Text Key: 104935826
• Report Number: 0002249697-2018-01066
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 52