MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS SM 12MM; KNEE OTHER IMPLANT

Catalog Number	198727212
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
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
Customer reported to (b)(6): implantation of knee-tep left side on (b)(6) 2017.Revision on (b)(6) 2017 because of patella luxation/subluxation.As per surgery report dated (b)(6) 2017: "¿patella is centered.The prothesis itself is well fixed in the bone.Inspection of inlay shows that the axis is disconnected from pe-inlay.So the rotation of femur is free; inlay does not participate rotation.".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > conclusion and justification status: the complaint states implantation of knee-tep left side on (b)(6) 2017.Revision on (b)(6) 2017 because of patella luxation/subluxation.As per surgery report dated 16-may-2017: "¿patella is centred.The prothesis itself is well fixed in the bone.Inspection of inlay shows that the axis is disconnected from pe-inlay.So the rotation of femur is free; inlay does not participate rotation." the medical records and devices were reviewed by bioengineering; the medical records did not provide further information that could assist in identifying the root cause of this complaint.The patient was revised for patella subluxation, upon revision, it was discovered that the metal hinge pin had disassociated from the poly insert.Patella was positioned centrally.The 14mm insert was revised by a 16mm insert.It is not possible to establish causation or correlation between the reported patella subluxation and hinge pin disassociation.With regards to the insert; no malalignment or embedded debris identified, on the femoral bearing surface a hood score for pitting 1-5 was given, on the tibial bearing surface a hood score for abrasion was visible, and a hood score for deep scratching 6+ was given.A review of complaints databases and manufacturing records did not identify any anomalies.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).Device history lot = > c53536.Device history review = > dhr reviewed for lot c53536 no deviations or non-conformances were noted.Reassigned to sq for ri/coc review.Ri/coc reviewed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS SM 12MM
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6871947
• Report Number: 1818910-2017-24894
• Device Sequence Number: 1324849
• Product Code: KRO
• UDI-Device Identifier: 10603295079484
• UDI-Public: 10603295079484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 198727212
• Device Lot Number: 703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/14/2017; 04/13/2018
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/10/2017; 04/17/2018
• 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: 78 YR