MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 30MM 127° NECK TRIAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1020-2730

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Color marking from the rasps crumble off.Replacement was available.

Event Description

Color marking from the rasps crumble off.Replacement was available.

Manufacturer Narrative

Conclusions: the reported event was confirmed as per material analysis performed on the returned product which concluded that the neck indicator fractured in multiple overload events.No identifiable material or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If the additional information is received, this investigation will be reopened and re-evaluated.

• Brand Name: ACCOLADE 30MM 127° NECK TRIAL
• 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: 7569332
• MDR Text Key: 110078218
• Report Number: 0002249697-2018-01700
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327208030
• UDI-Public: 07613327208030
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1020-2730
• Device Lot Number: P8A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other