MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* FLUT TIB ROD 150X16MM; KNEE OTHER IMPLANT

Catalog Number	866444
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Tissue Damage (2104)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It states that the patient with abnormal gigantism will undergo revision because of fracture of s-rom noiles rotating hinge knee stem.Update nov 14, 2017 additional information received.Customer reported to (b)(6): change of tibial components of knee-tep on (b)(6) 2011.In (b)(6) 2017 a fracture of taper of tibial part of prosthesis was suspected after radiological examination.Revision with change of tibial components on (b)(6) 2017.Intraoperatively a fracture of taper at the connection of tibial plateau to tibial stem was seen.Update: 12/13/2017 medical records reviewed.In addition to what was previously reported, there was loosening of the tibial component of the noiles right-knee joint tep with screw breakage at the transition from sleeve to stem.The patient then had increased instability and falls.Radiographs are reported to show the tibial component disconnected.During this revision, the surgeon noted a discolored synovia in the manner of metallosis and an old hematoma.The medical notes reported that the patient was implanted with a noiles knee prosthesis on (b)(6) 2011 due to an infection of previous implant.Currently it is not known if those were depuy components.
Additional Manufacturer Narrative
(b)(4).Investigation summary: complaint description states that the patient with abnormal gigantism will undergo revision because of fracture of s-rom noiles rotating hinge knee stem.It was visually confirmed that the tibial stem had fractured.A blue stain was noted on the bearing surface of the tibial tray.Part of the cement used between the back face of the tibial tray and the top face on the tibial sleeve covered the fixation surface of the tibial sleeve.The tibial stem was found broken and part of the inserting pin of the stem was retained within the tibial sleeve.A crack was noted on the anterior aspect of the distal tibial sleeve.It was not possible to assess the tibial taper region because the tibial tray was retained within the tibial sleeve.Two holders were also returned with the parts.From the information reviewed by our laboratory and bio engineers it was noted that it was unlikely that a manufacturing defect was present.The complaint shall be closed with an undetermined: no product problem identified.No corrective action is required.The occurrence shall be put monitored through our companies post market surveillance system for future trends.The products shall be retained and stored in a secure area for future analysis unless specifically requested back by the customer device history lot: 281502.Device history review: a review of the manufacturing records and the material certificates identified that no anomalies or non-conformance's were noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7118657
• Report Number: 1818910-2017-29709
• Device Sequence Number: 1004870
• Product Code: JWH
• UDI-Device Identifier: 10603295217121
• UDI-Public: 10603295217121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 866444
• Device Lot Number: 281502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 05/10/2018
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 130