MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTPILLAR TMZF SIZE 5 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 5353-0-105

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 08/02/2023

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.H3 other text : device not returned to the manufacturer.

Event Description

This is a case of a head in the list of implants that may be misaligned with v40.The patient was revised with armed suspicion.The head was removed, and although some corrosion was observed, there was no fracture, so the head and insert were replaced.Although the cause cannot be identified, there is a high possibility that armed was caused by neck traniosis from the joint between the head and neck.The surgery was successfully completed by scraping the inside of the joint and replacing the head insert.

Manufacturer Narrative

Reported event: an event regarding corrosion involving a centpillar stem that was mated with a lfit v40 cocr head was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to armd (adverse reaction to metal debris).The reported stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This is a case of a head in the list of implants that may be misaligned with v40.The patient was revised with armed suspicion.The head was removed, and although some corrosion was observed, there was no fracture, so the head and insert were replaced.Although the cause cannot be identified, there is a high possibility that armed was caused by neck traniosis from the joint between the head and neck.The surgery was successfully completed by scraping the inside of the joint and replacing the head insert.

• Brand Name: CENTPILLAR TMZF SIZE 5 LEFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17622358
• MDR Text Key: 321920424
• Report Number: 0002249697-2023-00946
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

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: 07/31/2016
• Device Catalogue Number: 5353-0-105
• Device Lot Number: 37223604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2011
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian