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

Catalog Number 1236-2-848

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Loss of Range of Motion (2032); Injury (2348); Joint Dislocation (2374)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision tha on a patient that received a mdm in 2011.28mm delta head was dislocated from the 42mme poly.Replaced with a 36mm "e" 0 degree x3 poly and 36mm +7.5 c-taper delta head with the v40/c-taper conversion sleeve.

Manufacturer Narrative

After event description update from disassociation to dislocation was noted, the reportable subject device was changed.Corrected information has been provided in the following sections: expiration date removed as lot code is unknown, g5 510k updated as per catalog number update, manufacture date removed as lot code is unknown.An event regarding dislocation (disassociation) involving an adm liner was reported.The event was confirmed following a review of the provided x-rays.The device was not returned however images of the device were provided.The adm liner showed a large dent on the outer rim of the adm liner consistent with the neck of the stem contacting with the liner.A review of the provided x-rays by a clinical consultant concluded "procedure-related factors: not enough info for full evaluation of potential component malposition while still suspect given the clinical context of the case but not evident from current information.Heterotopic ossifications are also related to surgical approach and technique.Patient-related factors heterotopic ossifications, brooker grade-3, have patient-related characteristics due to genetic predisposition.Hip capsule laxity after previous revision procedure.Obesity (b)(6), a secondary factor.Device-related factors: none.Heterotopic ossifications brooker grade-3 causing limitation in range of movement in the hip with bony impingement effects caused a hip dislocation where the design characteristics of the adm determined an intraprosthetic dislocation requiring revision.Obesity and previous revision history, possibly also for dislocation, represented additional secondary factors while additional component malposition is suspected but cannot be proven with the current information." a review of the device history records could not be performed as no lot details were provided complaint history review: not performed as no product lot details were provided.The investigation concluded that "heterotopic ossifications brooker grade-3 causing limitation in range of movement in the hip with bony impingement effects caused a hip dislocation.Obesity and previous revision history, possibly also for dislocation, represented additional secondary factors while additional component malposition is suspected but cannot be proven with the current information." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Revision tha on a patient that received a mdm in 2011.28mm delta head was dislocated from the 42mme poly.Replaced with a 36mm "e" 0 degree x3 poly and 36mm +7.5 c-taper delta head with the v40/c-taper conversion sleeve.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6937281
• MDR Text Key: 88973473
• Report Number: 0002249697-2017-02960
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2016
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 37379002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 114