MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 1236-2-848

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.

Event Description

Recurrent dislocating hip replacement.Surgeon reporting possible dissociation of mdm liner from head.Planned revision surgery for (b)(6).Initial primary hip replacement surgery (b)(6) 2019.Update on 04/december/2019 wg: intra-op images show that the femoral head was not seated in the adm insert (disassociation) and the adm insert was not locked into the mdm metal liner (dislocation).No further information will be released by the surgeon.

Manufacturer Narrative

An event regarding disassociation of the head from the adm liner involving an adm liner was reported.The event was confirmed by intra-operative photographs provided.Method & results: device evaluation and results: revision surgery intra-operative photographs were provided for review.From the photographs we can see that the head disassociated from the adm x3 liner and that the adm x3 liner has dislocated from the mdm (metal) liner.A photograph of the 3 explanted devices: the head, mdm liner and adm liner was also provided with nothing remarkable to note.The reported devices were also returned for evaluation.The bearing surface of the returned adm liner appears unremarkable.Damage appears on the rim of the device consistent with implantation/explantation damage.The liner otherwise appears unremarkable.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: received x-ray image dated 2019 confirms dislocated hip, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 4 other similar events for the reported lot.Pr's (b)(4) are for the same patient for hip dislocation before revision surgery took place.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to fully investigate the event.If further information becomes available to indicate further evaluation is warranted, this investigation will be re-opened.

Event Description

Recurrent dislocating hip replacement.Surgeon reporting possible dissociation of mdm liner from head.Planned revision surgery for on (b)(6).Initial primary hip replacement surgery on (b)(6) 2019.Update 04/december/2019 wg: intra-op images show that the femoral head was not seated in the adm insert (disassociation) and the adm insert was not locked into the mdm metal liner (dislocation).No further information will be released by the surgeon.

• Brand Name: RESTORATION ADM X3 INS 28/48
• 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: 9481237
• MDR Text Key: 182715506
• Report Number: 0002249697-2019-04037
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (y/n): N
• PMA/PMN Number: K093644
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 70155501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 50