MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ2 STD; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-03-080
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
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 patient was revised to address loosening of the stem at the cement to implant interface.Cement manufacturer is unknown.Patient had an alval on the side of her hip leading the surgeon to believe that the hip prosthesis was having micromotion causing some metal wear.Originally implants were a cobalt chrome summit cemented stem with a cobalt chrome spacer and monopolar hemi arthroplasty head.She was revised to a total hip with a pinnacle cup, altrx liner, screw, corail revision, and delta ceramic head.Lack of metalosys in joint but raised ion levels pre op.Doi: (b)(6) 2018, dor: (b)(6) 2021, affected side: unknown hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT CEMENTED STEM SZ2 STD
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12513534
• Report Number: 1818910-2021-20781
• Device Sequence Number: 11740716
• Product Code: JDI
• UDI-Device Identifier: 10603295059523
• UDI-Public: 10603295059523
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 09/01/2021

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: 1570-03-080
• Device Catalogue Number: 157003080
• Device Lot Number: D17094049
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEMENTRALIZER 8.5MM; MODULAR CATHCART BALL 44MM OD; SUMMIT CEMENTED STEM SZ2 STD; TAPERED SPACER ARTICUL/EZE +5; CEMENTRALIZER 8.5MM; MODULAR CATHCART BALL 44MM OD; SUMMIT CEMENTED STEM SZ2 STD; TAPERED SPACER ARTICUL/EZE +5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80