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

Catalog Number UNK_JR

Device Problems Insufficient Information (3190); Difficult or Delayed Separation (4044)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2020

Event Type  Injury  

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.

Event Description

Primary procedure, right hip.It was reported that the impactor bolt became stuck in the shell, and that the impactor sheared off where the handle meets the curved part of the impactor.All devices (including the shell) were removed from the patient and another shell was implanted.Surgery was completed successfully with a delay of approximately 2 minutes.Rep may be able to provide some additional patient information, otherwise confirmed that no further information will be released by the hospital or surgeon.

Event Description

Primary procedure, right hip.It was reported that the impactor bolt became stuck in the shell, and that the impactor sheared off where the handle meets the curved part of the impactor.All devices (including the shell) were removed from the patient and another shell was implanted.Surgery was completed successfully with a delay of approximately 2 minutes.Rep may be able to provide some additional patient information, otherwise confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding disassembly involving an unknown impactor bolt and a trident shell was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as product was not returned.  clinician review: no medical records were received for review with a clinical consultant.   device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product return and details as well as images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.

• Brand Name: UNKNOWN_IMPACTOR BOLT
• 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: 10307938
• MDR Text Key: 199865668
• Report Number: 0002249697-2020-01527
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR