MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP PC STEM 10 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1130-10-200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/21/2021
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
Surgeon elected to perform a left shoulder revision arthroplasty on a patient who he performed a primary total shoulder arthroplasty on (b)(6) 2010.Surgeon noted that the patient performed well post operatively after her primary shoulder arthroplasty until 2018 when she experience several dislocations.Surgeon did not specify the exact number of dislocations of the left shoulder.Most recent dislocation happened on (b)(6) 2021 and doctor noted they had difficulty reducing the patient¿s shoulder this time but were successful in reducing it.Afterwards he saw the patient in clinic and took films which showed a separation of the humeral implant at the 135 degree tapered neck spacer and the humeral stem.The tapered spacer and humeral head construct remained intact.Doctor then elected to revise the patient¿s shoulder due to the separation on wednesday, (b)(6) 2021 at (b)(6) hospital.Upon exposure to the left shoulder cuff surgeon felt the cuff was compromised severely enough to warrant a reverse shoulder replacement thus requiring all primary components to be revised.Doctor was able to remove the tapered neck spacer and humeral head construct with his hand.He then used osteotomes, mallet, and kochers to loosen and remove the well fixed anchor peg glenoid.Finally he used osteotomes, a mallet, and the system broach handle and adapter to loosen the well fixed humeral stem and explant it.There was not indication by anyone that the components did not perform as expected.Nothing broke during the revision procedure and there were no time delays.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no devices associated with this report were received for examination.All available x-rays and photos were reviewed, and evidence of implants disassociation between humeral head and stem was found.Additionally, the glenoid anchor was found slightly deformed and several nicks were identified.Faded marks prints were found on the stem as well as nicks.No anomalies were identified on the tapper assembly.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: GLOBAL AP PC STEM 10 MM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12317069
• Report Number: 1818910-2021-17774
• Device Sequence Number: 4712714
• Product Code: MBF
• UDI-Device Identifier: 10603295005513
• UDI-Public: 10603295005513
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 07/21/2021

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: 1130-10-200
• Device Catalogue Number: 113010200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: CROSSLINK ANCHOR PG GLENOID 44; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 44X15 ECC; GLOBAL AP PC STEM 10 MM; CROSSLINK ANCHOR PG GLENOID 44; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 44X15 ECC; GLOBAL AP PC STEM 10 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 86