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

Catalog Number UNK_JR

Device Problems Break (1069); Fracture (1260)

Patient Problems Hip Fracture (2349); Ambulation Difficulties (2544)

Event Date 11/06/2020

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

The surgeon reported that the exeter stem broke and required revision.

Event Description

The surgeon reported that the exeter stem broke and required revision.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an unknown exeter stem was reported.The event was confirmed through material analysis of the returned device.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report.This inspection indicated: the stem was returned in the fractured condition.A material analysis has been performed.The report concluded: plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.The fracture morphology was consistent with a fatigue fracture with final fracture occurring in overload.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.Eds analysis showed that the stem is consistent with the drawing (an astm f1586 alloy).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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.  conclusions: visual inspection was performed as part of the material analysis report.This inspection indicated: the stem was returned in the fractured condition.A material analysis has been performed.The report concluded: plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.The fracture morphology was consistent with a fatigue fracture with final fracture occurring in overload.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.Eds analysis showed that the stem is consistent with the drawing (an astm f1586 alloy).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN_EXETER STEM
• 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: 10913239
• MDR Text Key: 218521825
• Report Number: 0002249697-2020-02557
• 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
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention