MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR 10D 540DX36ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number	2218-36-154
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported as "trials in poor condition.".
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Territory 239 reported as "trials in poor condition." examination of the returned instrument confirmed the complaint; liner is worn and heavily scratched.The complaint sample consisted of (1) 221836154- pin trl lnr 10d 540dx36id, date code cy1203.The date code cy1203 indicates this device was manufactured in dec 2003 and is 18 years old.A five-year search of the complaint database found similar reports for this type of damage and the root cause was attributed to a combination of misuse and heavy usage.No evidence was found of product or design error as a contributing factor.Monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PIN TRL LNR 10D 540DX36ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• 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 av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 12836666
• Report Number: 1818910-2021-25589
• Device Sequence Number: 4529013
• Product Code: HWT
• UDI-Device Identifier: 10603295101277
• UDI-Public: 10603295101277
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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: 2218-36-154
• Device Catalogue Number: 221836154
• Device Lot Number: CY1203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2003
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown