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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
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 review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been 4 other similar events for the lot referenced.
Event or Problem Description
As reported: "stem extraction device broke during procedure.Slight delay (approximately 2 minutes) in case as we needed to open a second extraction device.It was just outside the or." procedure was a left hip revision.Spoke to rep, who provided a device picture and reported he may be able to return the device, otherwise confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
As reported: "stem extraction device broke during procedure.Slight delay (approximately 2 minutes) in case as we needed to open a second extraction device.It was just outside the or." procedure was a left hip revision.Spoke to rep, who provided a device picture and reported he may be able to return the device, otherwise confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a gmrs impactor adaptor was reported.The event was confirmed via provided photo.Method & results product evaluation and results: the reported device was not returned however a photograph was provided for review.The photo presented the device with the treaded portion fractured.The reported event is confirmed.Clinician review: a review of the provided medical information by a clinical consultant indicated: confirmation: the event of a revision can be confirmed based on implant stickers, use of a mcreynolds adapter can also be confirmed.The side of the revision, reason for the revision, and the breakage of the extraction device cannot be confirmed.Root cause: the root cause of the revision and the breakage of the extraction device cannot be ascertained without additional medical records, radiographs and perhaps the device itself.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock between with no relevant reported discrepancies.Complaint history review: there have been 6 other similar events for the lot referenced.Conclusions: the provided photo confirmed that the device fractured at the treaded portion.The reported event is confirmed.However, the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device is needed to complete the investigation for determining root cause.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
• MDR Report Key: 11341959
• Report Number: 0002249697-2021-00292
• Device Sequence Number: 3408936
• Product Code: LPH
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153345
• 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): 03/16/2021

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: 05/31/2015
• Device Model Number: 6260-4-090
• Device Catalogue Number: 6260-4-090
• Device Lot Number: TACL506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR