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

Catalog Number	6260-4-090
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding thread damage involving a gmrs adaptor was reported.The event was not confirmed.Method & results: product evaluation and results: the device was not returned for inspection; however, a photograph was provided for review.The photograph show a impactor adaptor, some dislocation is observed.Thread damage cannot be confirmed based on the photo.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the threads sheared off while attempting to remove the stem.Further information such as return of the device, as well as the device lot number are needed to further investigate root cause.No further investigation for this event is possible at this time.If the device and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During revision while attempting to remove the restoration modular stem, the mcreynolds adaptor sheared off at the threads.Surgeon decided to use a brand new proximal body without a screw to avoid performing a full osteotomy although rep mentioned this was off-label.

• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20553402
• Report Number: 0002249697-2024-01468
• Device Sequence Number: 21054153
• Product Code: LPH
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/28/2024

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 Catalogue Number: 6260-4-090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male