MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SM.UNIVERSAL CEMENT RESTRICTOR; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	B000-0185
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received will be provided in a supplemental report.Not available.
Event or Problem Description
Customer opened a package of a plug and it was missing.No item inside.
Event or Problem Description
Customer opened a package of a plug and it was missing.No item inside.
Additional Manufacturer Narrative
An event regarding a missing component involving a hip plug was reported.The event was not confirmed.Method & results: device evaluation and results: a visual inspection was performed.The box of the device was returned without the plastic wrapping.Only the implant labels were inside the box.Review of packaging by a supplier quality engineer indicated the product was likely in the packaging.Dhr and calibration reports were provided and supplier quality engineer noted: "dhr has the shipper box weights for the 7 boxes.They all weighed 13.30 lbs.Each.Additionally page 2 of the calibration of the scale states that the tolerance of the scale at +/-.03 lbs.The inner packaging and product was weighed at.13 lbs.Since this weight is above the tolerance and each shipper weighs the same, the product was likely to have been in the packaging and thus it is unlikely that this issue was caused during the manufacturing of the product." medical records received and evaluation: not performed as no medical records received.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the reported event could not be confirmed nor the root cause determined.Evaluation of the returned box was performed by a supplier quality engineer who indicated the product was likely to have been in the packaging and thus it is unlikely that this issue was caused during the manufacturing of the product.No further investigation is required at this time.If additional relevant information becomes available, this investigation will be reopened.

• Brand Name: SM.UNIVERSAL CEMENT RESTRICTOR
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7637835
• Report Number: 0002249697-2018-01963
• Device Sequence Number: 1645365
• Product Code: JDI
• UDI-Device Identifier: 07613153768111
• UDI-Public: 07613153768111
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K924323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2022
• Device Catalogue Number: B000-0185
• Device Lot Number: 6M9466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other