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

Catalog Number 6260-4-090

Device Problems Crack (1135); Fracture (1260); Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8457823
• MDR Text Key: 140141595
• Report Number: 0002249697-2019-01462
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6260-4-090
• Device Lot Number: TACKA0E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other