MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 15 X 195MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6276-7-115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 21mm mod rev hip body/bolt stdcomponent level 9006-1-021; cat # 6276-1-021; lot # 69506804.Delta v-40 ceramic head 36/-5; cat # 6570-0-036; lot # 73421403.Trochanteric grip plate; cat # 6704-3-093; lot # g5547829.D-m 2.0mm beaded cable set vit; cat # 6704-0-520; lot # 70424006.Md vit slv and 2.0mm homog cbl; cat # 6704-0-510; lot # 68966003.Md vit slv and 2.0mm homog cbl; cat # 6704-0-510; lot # 54941805.Md vit slv and 2.0mm homog cbl; cat # 6704-0-510; lot # 70142301.Md vit slv and 2.0mm homog cbl; cat # 6704-0-510; lot # 71025102.Md vit slv and 2.0mm homog cbl; cat # 6704-0-510; lot # 70835708.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: patient reports ongoing pain after an osteotomy procedure involving stryker implants.Patient had a primary competitor hip prior to procedure and currently has a competitor liner.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a restoration modular stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the first x-ray shows a press fit tha with the stem positioned in a varus orientation.The acetabulum is appropriately positioned and appears well fixed.The second x-ray shows the stem has been converted to a restoration modular which is in anatomic position.There is a long trochanteric plate with multiple cerclage cables.The x-rays are consistent with a revision surgery including extended trochanteric osteotomy.There is no evidence for mechanical complication following revision tha surgery.The root cause for ongoing pain following revision tha with osteotomy cannot be determined from the documentation provided.Should further documentation become available, i would be happy to further this investigation.".Product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient is experiencing pain following an osteotomy procedure."the first x-ray shows a press fit tha with the stem positioned in a varus orientation.The acetabulum is appropriately positioned and appears well fixed.The second x-ray shows the stem has been converted to a restoration modular which is in anatomic position.There is a long trochanteric plate with multiple cerclage cables.The x-rays are consistent with a revision surgery including extended trochanteric osteotomy.There is no evidence for mechanical complication following revision tha surgery.The root cause for ongoing pain following revision tha with osteotomy cannot be determined from the documentation provided.Should further documentation become available, i would be happy to further this investigation.".No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following device were also listed in this report: d-m 2.0mm beaded cable set vit; cat # 6704-0-520; lot # 70424006.It cannot be determined which, if any of these device may have caused or contributed to the patient's experience.

• Brand Name: MOD CON DIST STEM 15 X 195MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23451177
• Report Number: 0002249697-2025-01278
• Device Sequence Number: 15424965
• Product Code: JDI
• UDI-Device Identifier: 07613154058617
• UDI-Public: 07613154058617
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 6276-7-115
• Device Lot Number: CAXT112E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2015
• 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: 53 YR
• Patient Sex: Male