MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2101-0200

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Primary procedure, right hip.It was reported that the cup inserter would not attach to the cup.Upon inspection, the threads were observed to be malformed.Another inserter was immediately available and was used instead, no surgical delay was caused.

Manufacturer Narrative

An event regarding thread damage (¿the cup inserter would not attach to the cup¿) involving a cutting edge impactor was reported.The event was confirmed by visual inspection and mar analysis.Conclusions the reported event of ¿the cup inserter would not attach to the cup.Upon inspection the threads were observed to be malformed.¿ the event was confirmed based on a visual inspection which noted that the top thread was bent and a material analysis engineer noted, ¿in-service use damage observed on the device.Plastic deformation observed on the threads of the device, likely due to contact against a hard object.¿.

Event Description

Primary procedure, right hip.It was reported that the cup inserter would not attach to the cup.Upon inspection, the threads were observed to be malformed.Another inserter was immediately available and was used instead, no surgical delay was caused.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• 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: 7289995
• MDR Text Key: 100919127
• Report Number: 0002249697-2018-00527
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2101-0200
• Device Lot Number: B1MAK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 68