MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-5-132

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/09/2019

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.Device not returned.

Event Description

It was reported that the tha was done at (b)(6) 2011.After that, the patient complained of pain and melting of bone was recognized at the x-p.Therefore, revision surgery was done for all left hip implant.The black foreign body was recognized just below the fitting portion of the head and stem.

Event Description

It was reported that the tha was done at (b)(6) 2011.After that, the patient complained of pain and melting of bone was recognized at the x-p.Therefore, revision surgery was done for all left hip implant.The black foreign body was recognized just below the fitting portion of the head and stem.

Manufacturer Narrative

An event regarding osteolysis involving a stem, screws and plug was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.The metal head was returned for analysis.Scratching consistent with in-service use was observed on the articulating surface of the head.Damage present on the surface of the taper is consistent with interaction between the head and trunnion.The head does not interface directly with bone.During revision surgery, it is considered good surgical practice to always replace bearing components such as the tibial insert or hip liner including femoral head with new devices, also because service life damage or wear is not always readily visible and these components are usually modular and removal is easy and straightforward.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 32MM STD V40 TAPER VIT HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8860102
• MDR Text Key: 153243752
• Report Number: 0002249697-2019-02742
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• 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: 10/28/2019

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: 08/31/2016
• Device Catalogue Number: 6260-5-132
• Device Lot Number: 37527503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR