MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 14 X 155 MM; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6276-7-014
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
During a revision of patient's left hip, the proximal locking screw of the 23 +10 proximal body would not stay in the proximal body because the receiving hole was stripped.A 25 +10 proximal body was implanted with no proximal locking screw instead.
Additional Manufacturer Narrative
Corrected data: device information was corrected.An event regarding an intraoperative assembly issue due to damage involving a restoration modular stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: no medical records were received for review with a clinical consultant -device history review: all devices 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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including intra operative reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
During a revision of patient's left hip, the proximal locking screw of the 23 +10 proximal body would not stay in the proximal body because the receiving hole was stripped.A 25 +10 proximal body was implanted with no proximal locking screw instead.

• Brand Name: MOD CON DIST STEM 14 X 155 MM
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8117142
• Report Number: 0002249697-2018-03865
• Device Sequence Number: 1487119
• Product Code: LPH
• UDI-Device Identifier: 04546540641151
• UDI-Public: 04546540641151
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 12/30/2020
• Device Catalogue Number: 6276-7-014
• Device Lot Number: CAXT808A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/09/2019
• 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: 45 YR