MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD PLASMA HA STM 14MM X 127MMRESTORATION MODULAR HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-5-014
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding foreign matter.There have been no other similar events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that, during a tha, when a nurse opened an outer blister package, a surgeon found a hair on the inner blister package.
Event or Problem Description
It was reported that, during a tha, when a nurse opened an outer blister package, a surgeon found a hair on the inner blister package.
Additional Manufacturer Narrative
An event regarding foreign matter (hair on the packaging) with a restoration modular stem was reported.The event was confirmed through visual inspection.Method & results: device evaluation and results: visual inspection: visual inspection of the returned device indicates the presence of a hair on the inner blister package.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: nc has been raised to investigate the event.No correction is required as a result of this non-conformance.The part was used by the surgeon as the sterile barrier was not compromised and the packaging was returned.It can be concluded that this is an isolated occurrence.

• Brand Name: MOD PLASMA HA STM 14MM X 127MMRESTORATION MODULAR HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8312287
• Report Number: 0002249697-2019-00665
• Device Sequence Number: 2202822
• Product Code: LPH
• UDI-Device Identifier: 04546540641830
• UDI-Public: 04546540641830
• Combination Product (Y/N): N
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 08/31/2022
• Device Catalogue Number: 6276-5-014
• Device Lot Number: 58668101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/18/2019
• 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
• Patient Age: 82 YR