MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-52D

Device Problems Material Separation (1562); Sticking (1597); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported, "inner tyvek was stuck to outer one.Inner tyvek was separated to two sheets.So, sterility was kept barely.".

Manufacturer Narrative

An event regarding the tyvek lids sticking together involving a primary tritanium hemi cluster hole cup 52mm was reported.The event was confirmed.Method & results: -device evaluation and results: visual evaluation of the returned device packaging confirmed that inner blister tyvek lid was stuck to the outer lid.-medical records received and evaluation: not performed as no patient information was provided for review.-device history review: a device history review indicated that all devices that were accepted into final stock conformed to specification.-complaint history review: a complaint history review indicated that there have been no similar events for the reported lot.Conclusions: the investigation concluded that tyvek lids sticking was caused by a known packaging issue.Packaging innovation is aware of this, and has issued a memo.Due to the infrequent nature of these complaints and the greater risk that would be presented by an undersized foam, these events will not be addressed through a design change.

Event Description

It was reported, "inner tyvek was stuck to outer one.Inner tyvek was separated to two sheets.So, sterility was kept barely.".

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
• 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-CORK; ida industrial estate; carrigtwohill 00000
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5140682
• MDR Text Key: 28246751
• Report Number: 0002249697-2015-03279
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 502-03-52D
• Device Lot Number: JA6P2X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other