MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCREYNOLDS IMPACTOR ADAPTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6260-4-090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device noted as returned.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.
Event or Problem Description
It was reported that during a revision of the patient's right hip, the mcreynolds adapter broke off while extracting an accolade ii stem.Surgery was completed successfully with no delay.
Event or Problem Description
It was reported that during a revision of the patient's right hip, the mcreynolds adapter broke off while extracting an accolade ii stem.Surgery was completed successfully with no delay.
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a gmrs impactor adaptor was reported.The event was confirmed via evaluation of the returned device.Method & results product evaluation and results: visual inspection indicated the device is fractured near the threads.Pi reported ¿during a revision of the patient¿s right hip, the mcreynolds adapter broke off while extracting an accolade ii stem¿ the event occurred on a mcreynolds impactor adapter.The component was returned for investigation.Characterization using stereo microscopy and scanning electron microscopy confirmed the component fractured due to brittle overload.Mechanical damage was observed at the threaded section of the adapter, near the fracture surface.No manufacturing or material related defects were observed on the device surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding fracture of a gmrs adaptor was reported.Visual inspection indicated the device is fractured near the threads.Pi reported ¿during a revision of the patient¿s right hip, the mcreynolds adapter broke off while extracting an accolade ii stem¿ the event occurred on a mcreynolds impactor adapter.The component was returned for investigation.Characterization using stereo microscopy and scanning electron microscopy confirmed the component fractured due to brittle overload.Mechanical damage was observed at the threaded section of the adapter, near the fracture surface.No manufacturing or material related defects were observed on the device surfaces examined.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.

• Brand Name: MCREYNOLDS IMPACTOR ADAPTER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 15137408
• Report Number: 0002249697-2022-01111
• Device Sequence Number: 15284753
• Product Code: LPH
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 6260-4-090
• Device Catalogue Number: 6260-4-090
• Device Lot Number: TDEX400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG