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	Fall (1848); Pain (1994); Ambulation or Postural Difficulties (2544); Limb Fracture (4518)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
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
The patient was revised for aseptic loosening.Doi: (b)(6) 2013; dor: (b)(6) 2018; affected side : unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available xrays images were reviewed.Based on the xray evidence, complaint cannot be confirmed.No loosening condition was observed on depuy's device.No radiolucency can be observed around stem and considering poor condition of the patient's bone, it cannot be determine a progressive decay of implant position in relation to initial implantation position.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.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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13542825
• Report Number: 1818910-2022-02932
• Device Sequence Number: 17218183
• Product Code: LPH
• UDI-Device Identifier: 10603295079187
• UDI-Public: 10603295079187
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 324966
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2013
• 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: LPS CEMENTED STEM 13X125MM STR; LPS DISTAL FEM COMP XXSM LT; LPS INSERT TIBIAL HINGE UNIVERSAL 18MM XXSM; MBT TRAY POROUS SLEEVE 29MM CEMENTED; MBT TRAY SZ 2 PLUS 25MM THICK; S&N CEMENT RESTRICTOR 129418/12FSM0022; S&N CEMENT RESTRICTOR 129419/13ASM0024; SIGMA TAPER STEM 13MM X 90MM CEMENTED; STRYKER CEMENT 61971010; STRYKER CEMENT 61971010; STRYKER CEMENT 61971010; STRYKER CEMENT 61971010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 70 KG