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

Catalog Number UNK_JR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Inflammation (1932); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/06/2020

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

As reported: "revision for head dissociation due to trunnion wear and damage.Intraoperative findings were metallosis with stem trunnion damage.Dissociated head.Stem was removed.Competitive stem was reimplanted.Existing cup and screws were retained and a new liner placed.".

Event Description

As reported: "revision for head dissociation due to trunnion wear and damage.Intraoperative findings were metallosis with stem trunnion damage.Dissociated head.Stem was removed.Competitive stem was reimplanted.Existing cup and screws were retained and a new liner placed.".

Manufacturer Narrative

An event regarding disassociation involving an unknown metal head¿ was reported.¿the event was confirmed.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The provided photographs show recently explanted metal head, stem and poly liner.Damage consisting of loss of taper lock on the stem trunnion was observed.-clinician review: a review of the provided x-ray by a clinical consultant indicated: undated x-ray ap pelvis with uncemented right tha with disassociated and dislocated trunnion from modular head which remains in the acetabular component.No patient demographics, no clinical or pmh, no operative reports, no examination of explanted components, no dated serial x-rays.Based upon the single x-ray submitted, the event description can be confirmed, but insufficient data is present for a medical report.-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: based upon the provided x-ray, the disassociation can be confirmed.The provided photographs show recently explanted metal head, stem and poly liner.Damage consisting of loss of taper lock on the stem trunnion was observed.The exact cause of the event could not be determined because insufficient information was provided.¿ additional information including device details, operative reports, progress notes, x-rays and return of the device 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: UNKNOWN_FEMORAL HEAD
• 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: 10102038
• MDR Text Key: 193046291
• Report Number: 0002249697-2020-00992
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• 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?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR