MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-53-307

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient had clicking and some pain over time.The surgeon performed an arthroscopy in the past and noticed the uni poly was lifting up in the front and he was concerned that it could be causing discomfort to the patient.The surgeon would like a letter back to him responding to what was causing the poly to be lifting up.He was wondering if the poly was out of spec.To the tray that was originally implanted.Doi: (b)(6) 2016; dor: (b)(6) 2019; left knee.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.\product complaint #
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> (b)(4).Investigation summary
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> the received device was forwarded to commercialized product development for evaluation.The investigation found no evidence of product malfunction of product error as a contributing factor to the reported event and the need for corrective action was not indicated.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The anterior lip of poly just lifted up 1-2mm.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records reviewed.On (b)(6) 2016, patient received a medial left knee unicompartmental arthroplasty, to address medial compartment osteoarthritis.There was no reported complication.On (b)(6) 2018, patient's left knee was revised to address pain and suspected implant loosening.It was determined though, that there was no implant loosening--both femur and tibial tray components were well-fixed.Rather, it was identified that the tibial insert component locking mechanism had partially failed, with the insert moving in the tray.This insert component was revised, and scar tissue excised.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  additional narrative: h6 (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the received device was forwarded to commercialized product development for evaluation.The investigation found no evidence of product malfunction of product error as a contributing factor to the reported event and the need for corrective action was not indicated.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s or addition reports against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing that would contribute to the reported event.

• Brand Name: SIGMA HP UNI INS SZ3 7MM LM/RL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 46581-0988 ; 6107428552
• MDR Report Key: 9221438
• MDR Text Key: 176498380
• Report Number: 1818910-2019-111278
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002536
• UDI-Public: 10603295002536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-53-307
• Device Catalogue Number: 102453307
• Device Lot Number: C62712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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
• Treatment: COMPETITOR BONE CEMENT; SIGMA HP UNI FEMORAL SZ4 LM/RL; SIGMA HP UNI TIB TRAY SZ3 LMRL
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male