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

Catalog Number 2101-0200

Device Problems Loss of or Failure to Bond (1068); Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/23/2019

Event Type  malfunction  

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 upon routine inspection of hospital inventory, the junction of the metal rod and the handle of the cup inserter was loose.No associated procedure.

Manufacturer Narrative

An event regarding damage involving cutting edge impactor was reported.The reported event was confirmed.Conclusion: the device was discovered during inspection.The reported device was returned for evaluation.A material analysis has been performed.The report concluded: examination of the returned device with engineer indicated that the device is severely worn due to in service use.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that upon routine inspection of hospital inventory, the junction of the metal rod and the handle of the cup inserter was loose.No associated procedure.

• 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: 9214835
• MDR Text Key: 187599683
• Report Number: 0002249697-2019-03567
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other