MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1235-2-852
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional 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.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 or Problem Description
It was reported that the patient's right hip was revised.Surgeon reported his opinion that the patient fell, causing the stem to knock the adm/ mdm poly insert, partially dislodging it (no dislocation or dissociation), and continued to impinge on one side of the liner, causing wear.The adm/ mdm poly insert and 28mm metal head were revised to another adm/ mdm poly insert with a ceramic head and sleeve.Rep confirmed there are no allegations against the revised femoral head.Rep can provide additional pictures and catalog numbers/ lot codes for the devices, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event an event regarding damage and malposition (partial dislodging) involving a adm liner was reported.The event of damage was confirmed based on evaluation of implant pictures and event of malposition (partial dislodging) was not confirmed.Method & results -product evaluation and results: the reported device was not returned however photographs of adm liner were provided for review.The photographs show a recently explanted adm liner with significant damage on one side of the edge which is highly likely caused due to impingement with stem.From the photographs provided there is evidence of damage for the device.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient fell, causing the stem to knock the adm/ mdm poly insert, partially dislodging it (no dislocation or dissociation), and continued to impinge on one side of the liner, causing wear.Provided photographs show a recently explanted adm liner with significant damage on one side of the edge which is highly likely caused due to impingement.From the photographs provided there is evidence of impingement damage for the device.The event is likely caused by patient fall but the exact cause of the event could not be determined because insufficient information was provided.Further information such as evaluation of the reported device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.H3 other text : device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised.Surgeon reported his opinion that the patient fell, causing the stem to knock the adm/ mdm poly insert, partially dislodging it (no dislocation or dissociation), and continued to impinge on one side of the liner, causing wear.The adm/ mdm poly insert and 28mm metal head were revised to another adm/ mdm poly insert with a ceramic head and sleeve.Rep confirmed there are no allegations against the revised femoral head.Rep can provide additional pictures and catalog numbers/ lot codes for the devices, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: RESTORATION (TM) ADM. INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10147521
• Report Number: 0002249697-2020-01153
• Device Sequence Number: 13997398
• Product Code: LPH
• UDI-Device Identifier: 04546540638908
• UDI-Public: 04546540638908
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 1235-2-852
• Device Catalogue Number: 1235-2-852
• Device Lot Number: G2658633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR