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

Catalog Number 2101-0200

Device Problems Degraded (1153); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Socket can´t be removed/ turned off from the universal impactor.Replacement was available.

Manufacturer Narrative

An event regarding thread damage involving a cutting edge impactor was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection of the returned device was carried out by a material analysis engineer.On receiving the devices it was noted that they were disassembled.There was some minor damage at the base of the threads of the universal impactor likely due to misuse.Functional inspection: conducted a functional inspection with catalog number 2101-0200 cutting edge impactor lot code b4nav with catalog number 500-03-54e acetabular cup lot code 48078801.The cutting edge impactor was able to screw into the acetabular cup.Examination of the devices by the material analysis engineer indicated "there is some minor damage at the base of the threads of the universal impactor likely due to misuse." medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: a visual inspection of the returned device was carried out by a material analysis engineer indicated that there was some minor damage at the base of the threads of the universal impactor likely due to misuse.Functional inspection conducted with cutting edge impactor and acetabular cup.The cutting edge impactor was able to screw into the acetabular cup.The cause of the event is considered to be user error.

Event Description

Socket can´t be removed/ turned off from the universal impactor.Replacement was available.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6300476
• MDR Text Key: 66678168
• Report Number: 0002249697-2017-00447
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: B4NAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 85