MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ODC CEMENTED HIP #6 132; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 6070-0625

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 03/07/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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

It was reported that the patient's left hip was revised.As reported by rep: "loose stem in cement mantle." an osteonics hip stem and cement plug were revised.Rep provided usage sheets from primary and previous revision, and confirmed that no further information will be available.

Manufacturer Narrative

Reported event an event regarding loosening involving a omnifit stem was reported.The event was confirmed via medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: x-ray confirms loose stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: x-ray confirms loose stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient's left hip was revised.As reported by rep: "loose stem in cement mantle." an osteonics hip stem and cement plug were revised.Rep provided usage sheets from primary and previous revision, and confirmed that no further information will be available.

• Brand Name: ODC CEMENTED HIP #6 132
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9917788
• MDR Text Key: 186338945
• Report Number: 0002249697-2020-00676
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K922146
• 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: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2005
• Device Catalogue Number: 6070-0625
• Device Lot Number: S00C269B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 100 YR
• Patient Weight: 55