MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTPILLAR TMZF SIZE 6 LEFT; HIP IMPLANT

Catalog Number 5353-0-106

Device Problems Material Deformation (2976); Noise, Audible (3273)

Patient Problems Injury (2348); Reaction (2414)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.

Event Description

The patient underwent tha surgery with centpillar on (b)(6) 2009.The patient claimed abnormal sound from the left hip and a dislocation of the metal head was confirmed.Revision surgery was performed on (b)(6) 2018, and an insert, the metal head and the stem were replaced.Wear of the stem neck was noticed.Also, inside of the patient's hip joint was black by metal abrasion powder.

Manufacturer Narrative

An event regarding wear, altr & disassociation involving a centpillar stem was reported.The event of wear and disassociation was confirmed.Altr was not confirmed.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar).All surfaces of the neck exhibited damage, consistent with wear mechanisms due to the head taper and stem trunnion losing their taper lock in addition to explantation damage.Dimensional & functional inspection: not performed as there is evidence from the visual inspection that the device is damaged.Material analysis: a material analysis has been performed.The report concluded: damage was observed on the stem trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and stem trunnion losing their taper lock.Debris was observed in the taper of the head.Eds showed the stem and head chemistries were consistent with their drawing callouts and the debris was consistent with a corrosion product, biological material, material transfer from the stem, and an oxide.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms dissociation of the femoral head from the trunnion of the femoral stem with subsequent damage to the trunnion and head occurred.These events were caused by failure the taper lock between the head and trunnion.Conclusion: the clinician confirmed: "these events were caused by failure the taper lock between the head and trunnion, however, the root cause could not be determined.

Event Description

The patient underwent tha surgery with centpillar on (b)(6) 2009.The patient claimed abnormal sound from the left hip and a dislocation of the metal head was confirmed.Revision surgery was performed on (b)(6) 2018 ,and an insert, the metal head and the stem were replaced.Wear of the stem neck was noticed.Also, inside of the patient's hip joint was black by metal abrasion powder.

• Brand Name: CENTPILLAR TMZF SIZE 6 LEFT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7597101
• MDR Text Key: 110923023
• Report Number: 0002249697-2018-01799
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5353-0-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 09/26/2018
• 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: 118