MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; IMPLANT

Catalog Number 502-03-52D

Device Problems Device Packaging Compromised (2916); 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 10/07/2014

Event Type  malfunction  

Event Description

It was reported that during left total hip primary surgery, they were opening the package and found that the top layer of packaging was stuck to the inner layer, and then implant fell to the floor.Surgeon used a new implant without any delays in surgery.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding the foam packaging being stuck to the inner blister tyvek lid 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 attached to the top layer of packaging foam from the void-filling and heat sealing process.-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 foam packaging being stuck to the inner blister tyvek lid of a tritanium shell was caused by a known packaging issue.The raised foam during the sealing operation allowed for excessive contact of the sealing tool with the inner lidstock and packaging foam resulting in sealing or melting of the lidstock to the foam.It is related to a void-filling approach to sterile product packaging.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 that during left total hip primary surgery, they were opening the package and found that the top layer of packaging was stuck to the inner layer, and then implant fell to the floor.Surgeon used a new implant without any delays in surgery.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4215485
• MDR Text Key: 4973662
• Report Number: 0002249697-2014-04089
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2014

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 Expiration Date: 08/31/2019
• Device Catalogue Number: 502-03-52D
• Device Lot Number: MNM56K
• Other Device ID Number: STERILE LOT# MSHNM26A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 10/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2014
• 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
• Patient Age: 68 YR