MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 13X125MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-413
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Unspecified Infection (1930); Pain (1994)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to loosening of the femoral stem at the cement to implant interface.Depuy cement was used.It was also reported that the patient comes into emergency room and with pain and not feeling well.Xrays show heterotopic bone formation and what appears to be gas in tissues surrounding the implant, signifying infection.Once opened, gross pus was noted confirming infection.A thorough i&d with removal of heterotopic bone, exchange of components, placement of antibiotic beads and coating of prostheses with high dose antibiotic cement is performed.Cement was likely gmv with gent but would have been hospital owned so no lot info or confirmation is available in my records.No patient harm occurred.This patient does have multiple significant comorbidities which make her more prone to infection.Doi: (b)(6) 2021.Dor: (b)(6) 2023.Affected side: right hip.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.

• Brand Name: LPS CEMENTED STEM 13X125MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16195548
• Report Number: 1818910-2023-01376
• Device Sequence Number: 14968904
• Product Code: JWH
• UDI-Device Identifier: 10603295079187
• UDI-Public: 10603295079187
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1987-25-413
• Device Catalogue Number: 198725413
• Device Lot Number: J41G75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONTROL CABLE W/CABLE SLEEVE; LPS PROX FEM STD BODY 15DEG RT; LPS SEGMENTAL COMPONENT 105MM; LPS SEGMENTAL COMPONENT 35MM; UNKNOWN BONE CEMENT; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female