MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV WITH GENTAMICIN US 1 PACK; BONE CEMENT

Model Number	6195-1-001
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported upcoming left knee revision (scheduled (b)(6) 2022) due to loosening.Patient reported a successful primary surgery until april 2022 where she noticed a "lump" behind her left knee.Patient alleges surgeon noted loosening and "leaking" of cement.Patient did not report manufacturer of the knee implants aside from the cement.Patient noted surgeon advised of a potential stryker recall on the cement and patient would like to know if part of a recall.Patient wants compensation and is in the process of retaining an attorney.
Additional 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.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a simplex hv cement mix was reported.The event relates to product supplied by an oem.Conclusions: the reported device is an oem product.Oem supplier investigation results ref # (b)(4).Immediate action check of batch documentation of possible batches, no deviations.Root cause aseptic loosening, patient-specific cause presumably.Final risk assessment: the batch documentation showed no deviations.Aseptic loosening could have been caused by behavior of patient and physician during operation.Corrective action/preventive action: no action is required by stryker at this time as the investigation for this event is performed by the oem.
Event or Problem Description
Patient reported upcoming left knee revision (scheduled (b)(6) 2022) due to loosening.Patient reported a successful primary surgery until (b)(6) 2022 where she noticed a "lump" behind her left knee.Patient alleges surgeon noted loosening and "leaking" of cement.Patient did not report manufacturer of the knee implants aside from the cement.Patient noted surgeon advised of a potential stryker recall on the cement and patient would like to know if part of a recall.Patient wants compensation and is in the process of retaining an attorney.Update (b)(6) 2022: as reported in mw5111430: stryker hv cement was used in this patient's knee replacement which failed prematurely and had to be revised.The findings at surgery were consistent with failure of the cement product to bond to the implants.This resulted in a failure of the knee replacement which necessitated further surgery.Original surgery was 2017.Pain and swelling started about one year post surgery, work up was classic for hv cement failure as i have seen about 50 patients with this problem.I am just starting to report my cases t this time.As far as i am aware i may have used this product on approximately 350 patients over a time frame of about 3 years.I am predicting the failure rate for this product to approach 15-20% in a time frame of only about 1.5-2.5 years.The failure rate should be about (b)(4) per year.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14951979
• Report Number: 0002249697-2022-00983
• Device Sequence Number: 6896278
• Product Code: LOD
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG