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

Catalog Number UNK_SHC

Device Problem Material Erosion (1214)

Patient Problems Inflammation (1932); Injury (2348)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's left hip was revised due to trunnionosis.A 36 +0 lfit head and 36f 0° poly liner were revised to a 40f 0° poly liner and 40 +0 biolox head with sleeve.Rep confirmed there are no allegations against the revised liner, that the devices are allegedly available for return, and that no further information will be released by the hospital or surgeon.

Event Description

It was reported that the patient's left hip was revised due to trunnionosis.A 36 +0 lfit head and 36f 0° poly liner were revised to a 40f 0° poly liner and 40 +0 biolox head with sleeve.Rep confirmed there are no allegations against the revised liner, that the devices are allegedly available for return, and that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Correction to d9/h3 as this device remained implanted and therefore, not returned to the manufacturer.An event regarding alleged fretting involving an unknown accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product remained implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as device is not identified properly.Complaint history review: not performed as device is not identified properly.Conclusions: it was reported that patient was revised due to fretting.The exact cause of the event could not be determined because product is not properly identified and no further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : not returned to the manufacturer.

• Brand Name: UNKNOWN_ACCOLADE TMZF STEM
• 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: 10199753
• MDR Text Key: 196589999
• Report Number: 0002249697-2020-01302
• 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: 09/22/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR