MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_CORK_PRODUCT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problem Loss of Osseointegration (2408)

Patient Problems Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 02/14/2022

Event Type  Injury  

Event Description

Revision hip surgery performed.Surgeon reported that indication for surgery was degradation of bone surrounding the acetabular and femoral implants, and associated implant loosening.

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 to the manufacturer.

Manufacturer Narrative

Reported event: an event regarding loosening involving an unknown abg i stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 24 years post implantation due to polyethylene wear, bone degradation and loosening.I can confirm that this event took place since i was able to review pre-revision and post-revision xrays.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of poly wear, bone degradation and loosening are multifactorial including surgical technique factors, patient factors including activity level and bmi, and implant factors.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 24 years post implantation due to polyethylene wear, bone degradation and loosening.I can confirm that this event took place since i was able to review pre-revision and post-revision xrays.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of poly wear, bone degradation and loosening are multifactorial including surgical technique factors, patient factors including activity level and bmi, and implant factors.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Revision hip surgery performed.Surgeon reported that indication for surgery was degradation of bone surrounding the acetabular and femoral implants, and associated implant loosening.

• Brand Name: UNKNOWN_CORK_PRODUCT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 13711751
• MDR Text Key: 286863804
• Report Number: 0002249697-2022-00352
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male