MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS FEM TO SLEEVE ADAP +5 TRL; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2987-06-005
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (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
It was reported that the plus 5 adapter trial has been used before and was damaged when trying to take it out of the 31mm sleeve trial.The metal has been scraped up and the trials don¿t fit together correctly.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy 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: no lot information available.

• Brand Name: LPS FEM TO SLEEVE ADAP +5 TRL
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12154810
• Report Number: 1818910-2021-15006
• Device Sequence Number: 11937200
• Product Code: HWT
• UDI-Device Identifier: 10603295157625
• UDI-Public: 10603295157625
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 2987-06-005
• Device Catalogue Number: 298706005
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/17/2021
• Patient Sequence Number: 1