MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 626-00-46F

Device Problem Corroded (1131)

Patient Problems Pain (1994); Unequal Limb Length (4534)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Taking out this dual mobility liner and experience slight corrosion on back portion of liner that was slightly concerning to surgeon and he wanted it to be analyzed.Update 22/december/2020: this patient from what i understand presented with shortening of his hip on the operative (left) side due to a subsided stem as well as hip pain maybe from psoas rubbing on the implant.So that plan for the revision was to lengthen the operative leg with a new stem and keep the cup.

Event Description

Taking out this dual mobility liner and experience slight corrosion on back portion of liner that was slightly concerning to surgeon and he wanted it to be analyzed.Update (b)(6)2020: this patient from what i understand presented with shortening of his hip on the operative (left) side due to a subsided stem as well as hip pain maybe from psoas rubbing on the implant.So that plan for the revision was to lengthen the operative leg with a new stem and keep the cup.

Manufacturer Narrative

An event regarding corrosion involving a mdm liner was reported.The event was confirmed by evaluation of the returned device.      method & results:  -device evaluation and results: the device was received for evaluation.Black materials were noticed on the device.The liner base material and debris were analyzed using energy dispersive spectroscopy (eds).The eds analysis showed that the liner was consistent with the drawing (astm f1537) and that the debris was consistent with an oxide and corrosion product.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated:   no clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no dated serial x-rays.  based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.  -complaint history review: there have been no other similar events for the reported lot.  conclusion:  it was reported that when the surgeon took out this dual mobility liner, he noticed slight corrosion on back portion of liner.The device was received for evaluation.Black materials were noticed on the device.The liner base material and debris were analyzed using energy dispersive spectroscopy (eds).The eds analysis showed that the liner was consistent with the drawing (astm f1537) and that the debris was consistent with an oxide and corrosion product.The reported event was confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including clinical or patient medical history (pmh), patient demographics, operative reports, and dated serial x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11129665
• MDR Text Key: 225578647
• Report Number: 0002249697-2021-00050
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (y/n): N
• PMA/PMN Number: K103233
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 62233201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR