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	Unstable (1667)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Patient called and is inquiring about recall for her right knee surgery on (b)(6) 2016.Update on (b)(6) 2022: patient is experiencing instability.She has seen three different surgeons and has upcoming revision surgery in mid (b)(6).Patient would like to know what implants she can use in her revision for a better outcome.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving simplex cement mix was reported.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: patient specific cause is possible.Final risk assessment: to exclude a product specific cause, the batch documentation was checked, no deviations.A retain sample could not be done.Since the surgery is 6 years ago.It is not a early loosening, a product specific cause is unlikely.A patient specific cause is possible.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 called and is inquiring about recall for her right knee surgery on (b)(6) 2016.Update 13-apr-2022: patient is experiencing instability.She has seen three different surgeons and has upcoming revision surgery in mid (b)(6).Patient would like to know what implants she can use in her revision for a better outcome.

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14344861
• Report Number: 0002249697-2022-00675
• Device Sequence Number: 14995798
• Product Code: LOD
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-001
• Device Lot Number: 530BB597GW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 58 KG