MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0635
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: uhr bipolar 28x45mm; uh1-45-28 ;et4e63, delta v-40 ceramic head 28/0; 6570-0-128; 799733501.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following was reported: (b)(6) after bha.(2/4).
Event or Problem Description
The following was reported: mrsa after bha.(2/4).
Additional Manufacturer Narrative
Lot updated from 799733501 to 79733501 for delta v-40 ceramic head 28/0; 6570-0-128.Reported event: an event regarding infection involving an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection, functional, dimensional and material analysis of device could not performed as device remained implanted.Medical records evaluation: no medical reports were available for review device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot and for the sterile lot.Conclusions: the event of infection involving a accolade stem was reported.The event was not confirmed nor the root cause determined because insufficient medical information was provided.Further information such as more medical documentation are needed.Infection is a known possible adverse outcome of surgery, as noted in the instructions for use.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 6 ACCOLADE II 132 DEG
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11404183
• Report Number: 0002249697-2021-00366
• Device Sequence Number: 11608439
• Product Code: LPH
• UDI-Device Identifier: 04546540664495
• UDI-Public: 04546540664495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 6720-0635
• Device Catalogue Number: 6720-0635
• Device Lot Number: 66781101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other