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 Codes	Crack (1135); Fracture (1260); Misassembled (1398)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
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.Device not available.
Event or Problem Description
While performing a revision of patient's hip, the impactor adapter wasn't fully screwed into the stem.When the instrument was back slapped, the threads sheared off in the stem.Another device was immediately available and removal was completed with no surgical delay.Rep reported that the surgeon and hospital have no further information available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a gmrs adaptor was reported.The event was confirmed after review of the provided photograph.Method & results product evaluation and results: the reported device was not returned however a photograph was provided for review.Review of the photograph noted the following: the threaded end of the device has fractured just below the first thread.The device shows some staining from biological material but is otherwise, unremarkable.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the operative report as well as device return are 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.
Event or Problem Description
While performing a revision of patient's hip, the impactor adapter wasn't fully screwed into the stem.When the instrument was back slapped, the threads sheared off in the stem.Another device was immediately available and removal was completed with no surgical delay.Rep reported that the surgeon and hospital have no further information available.

• 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: 8457823
• Report Number: 0002249697-2019-01462
• Device Sequence Number: 16875399
• Product Code: LPH
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: TACKA0E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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