MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS 1.5X12.0 CALCAR 12/14; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number 157161000

Device Problems Biocompatibility (2886); Osseointegration Problem (3003)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 06/28/2004

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Ppf alleges loosening of stem.Doi: (b)(6) 2003- dor: (b)(6) 2004, (left hip).

• Brand Name: SOL SYS 1.5X12.0 CALCAR 12/14
• Type of Device: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 8508711
• MDR Text Key: 141746665
• Report Number: 1818910-2019-90527
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295061120
• UDI-Public: 10603295061120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157161000
• Device Lot Number: WY1C5D001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 91