MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-123
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The plastic s-rom/lps insert broke in two pieces when impacting at surgery.No hard instruments was used.Inserts was putting in right position and during examination of flexion/extension rom surgeon saw the metal part was lifting a bit from the plastic part.They were supposed to use insert xs 23 mm but since they just had one of each they had to use an insert 21 mm.Surgery delay 5 minutes.Procedure successfully completed no patient consequences.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device revealed no defect found.No evidence of product malfunction or product error was found.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: dhr reviewed.No deviations or nonconformance's were noted.

• Brand Name: LPS UNIV TIB HIN INS XSM 23MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11633960
• Report Number: 1818910-2021-07443
• Device Sequence Number: 3683993
• Product Code: KRO
• UDI-Device Identifier: 10603295079446
• UDI-Public: 10603295079446
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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 Model Number: 1987-27-123
• Device Catalogue Number: 198727123
• Device Lot Number: HJ5742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1